United States was the largest outside supplier.
What this market covers
External fixators hold broken bones in place using pins and a frame outside the body. They are used in trauma care, limb lengthening and deformity correction.
Typical segments
- Unilateral fixators
- Circular fixators
- Hybrid fixators
- Pediatric fixators
Source: Eurostat
Why this market is moving now
- Extra-EU import value rose 27% from 2020 to 2025, a direct read on EU demand for sourced supply.
- Supply is concentrated: one country provided a large share of extra-EU imports in 2025.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU imported €1.13 billion of products under CN code 90211090 (Splints and other fracture appliances) from outside the EU in 2025. | 1.13 EUR billion | 2025 | Eurostat |
| Extra-EU imports of CN 90211090 were up 27% in 2025 compared with 2020 (€887.2 million), calculated from Eurostat values. | +27 % since 2020 | 2025 | Eurostat |
| EU exports of CN 90211090 to countries outside the EU were worth €929.9 million in 2025. | 929.9 EUR million | 2025 | Eurostat |
| Trade between EU member states in CN 90211090 (intra-EU arrivals) came to €1.14 billion in 2025. | 1.14 EUR billion | 2025 | Eurostat |
| United States was the largest non-EU supplier of CN 90211090 to the EU in 2025, with €495.6 million, or 44% of extra-EU imports. | 495.6 EUR million | 2025 | Eurostat |
| EU exports of CN 90211090 to the United States were €388.7 million in 2025. | 388.7 EUR million | 2025 | Eurostat |
| The average value of extra-EU imports of CN 90211090 was €288.89 per kilogram in 2025, calculated from Eurostat value and weight. | 288.89 EUR per kg | 2025 | Eurostat |
| Germany was the largest EU exporter of CN 90211090 to non-EU countries in 2025, at €437.7 million. | 437.7 EUR million | 2025 | Eurostat |
| The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023. | 63,227 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021. | 105.31 EUR billion | 2021 | Eurostat |
| NACE class C3250 employed 600,000 people across the EU in 2023. | 600,000 persons employed | 2023 | Eurostat |
| The US had 3,528 private establishments in NAICS 339113 (Surgical appliance and supplies manufacturing) in 2025. | 3,528 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339113 employed an average of 105,116 people in US private industry in 2025. | 105,116 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339113 changed by +3% between 2020 (102,053 jobs) and 2025, calculated from BLS figures. | +3 % since 2020 | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339113 was $102,311 in 2025. | 102,311 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 44 510(k) clearances for devices named "external fixator". | 44 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 2 of those clearances were issued from 2021 to 2025. | 2 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Synthes (Usa) holds 10 510(k) clearances for devices named "external fixator". | 10 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Acu Med, Inc. holds 3 510(k) clearances for devices named "external fixator". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Nutek Orthopaedics, Inc. holds 2 510(k) clearances for devices named "external fixator". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 3D Medical Concepts, Llc holds 1 510(k) clearances for devices named "external fixator". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Aike (Shanghai) Medical Instrument Co., Ltd. holds 1 510(k) clearances for devices named "external fixator". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Avanta Orthopaedics, Inc. holds 1 510(k) clearances for devices named "external fixator". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 1
DS-045409, reporter EU27_2020, product 90211090, partner EXT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1127046779
- Figure 2
DS-045409, reporter EU27_2020, product 90211090, flow import, 2020 VALUE_IN_EUROS 887204884; 2025 VALUE_IN_EUROS 1127046779
- Figure 3
DS-045409, reporter EU27_2020, product 90211090, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 929887306
- Figure 4
DS-045409, reporter EU27_2020, product 90211090, partner INT_EU27_2020, flow import, 2025, VALUE_IN_EUROS 1136680598
- Figure 5
DS-045409, reporter EU27_2020, product 90211090, partner US, flow import, 2025, VALUE_IN_EUROS 495559564
- Figure 6
DS-045409, reporter EU27_2020, product 90211090, partner US, flow export, 2025, VALUE_IN_EUROS 388719276
- Figure 7
DS-045409, reporter EU27_2020, product 90211090, flow import, 2025, VALUE_IN_EUROS 1127046779, QUANTITY_IN_100KG 39013
- Figure 1
- Eurostat: EU trade since 1988 by HS2-4-6 and CN8 (DS-045409) (2026-11-04)
Quoted lines
- Figure 8
DS-045409, reporter DE, product 90211090, partner EXT_EU27_2020, flow export, 2025, VALUE_IN_EUROS 437684485
- Figure 8
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 9
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 10
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 11
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 9
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339113, 2025 (2026-11-04)
Quoted lines
- Figure 12
QCEW 2025 annual, US000, private, NAICS 339113, annual_avg_estabs 3528
- Figure 13
QCEW 2025 annual, US000, private, NAICS 339113, annual_avg_emplvl 105116
- Figure 14
QCEW 2020 annual_avg_emplvl 102053; 2025 annual_avg_emplvl 105116
- Figure 15
QCEW 2025 annual, US000, private, NAICS 339113, avg_annual_pay 102311
- Figure 12
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "external fixator" (2026-11-04)
Quoted lines
- Figure 16
openFDA device/510k device_name:"external fixator", sum of counts by decision_date = 44
- Figure 17
openFDA device/510k decision_date 2021-2025 count = 2
- Figure 16
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "external fixator" (2026-11-04)
Quoted lines
- Figure 18
applicant.exact "Synthes (Usa)" count 10
- Figure 19
applicant.exact "Acu Med, Inc." count 3
- Figure 20
applicant.exact "Nutek Orthopaedics, Inc." count 2
- Figure 21
applicant.exact "3D Medical Concepts, LLC" count 1
- Figure 22
applicant.exact "Aike (Shanghai) Medical Instrument Co., Ltd." count 1
- Figure 23
applicant.exact "Avanta Orthopaedics, Inc." count 1
- Figure 18
Buyers and suppliers
Who buys
- Hospitals
- Trauma surgeons
- Military medical services
Large non-EU suppliers to the EU
Companies to watch
Synthes (Usa)
10 FDA 510(k) clearances for devices named "external fixator".
Acu Med, Inc.
3 FDA 510(k) clearances for devices named "external fixator".
Nutek Orthopaedics, Inc.
2 FDA 510(k) clearances for devices named "external fixator".
3D Medical Concepts, Llc
1 FDA 510(k) clearances for devices named "external fixator".
Aike (Shanghai) Medical Instrument Co., Ltd.
1 FDA 510(k) clearances for devices named "external fixator".
Avanta Orthopaedics, Inc.
1 FDA 510(k) clearances for devices named "external fixator".
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the European Union market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
- Ready-to-use charts
- Method note and assumptions
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Frequently asked questions
How big is the EU external fixator market?
There is no single official market total. Eurostat trade data shows the EU imported €1.13 billion of goods under CN 90211090 from outside the EU in 2025 and exported €929.9 million.
Where does the EU import external fixator from?
United States was the largest non-EU supplier in 2025. Other large suppliers included Switzerland, Mexico, China.
What is the average import price of external fixator in the EU?
Dividing Eurostat import value by weight gives about €288.89 per kilogram for CN 90211090 in 2025.
Which EU countries export the most external fixator?
Germany led EU exports to non-EU countries in 2025, followed by Netherlands, Belgium.
How many external fixator devices are cleared by the FDA?
openFDA lists 44 510(k) clearances for devices named external fixator.
Which companies hold the most FDA clearances for external fixator?
By 510(k) count: Synthes (Usa), Acu Med, Inc., Nutek Orthopaedics, Inc., 3D Medical Concepts, Llc.
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