What this market covers
Carpal tunnel release systems are surgical devices used to cut the transverse carpal ligament and relieve pressure on the median nerve. They support open and endoscopic procedures.
Typical segments
- Endoscopic release systems
- Open release instrument sets
- Ultrasound guided release devices
- Single use release kits
Why this market is moving now
- US employment in the core industry shifted +4% since 2020.
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 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 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing) in 2025. | 4,547 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339112 employed an average of 140,413 people in US private industry in 2025. | 140,413 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339112 changed by +4% between 2020 (135,655 jobs) and 2025, calculated from BLS figures. | +4 % change | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339112 was $109,475 in 2025. | 109,475 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 9 510(k) clearances for devices named "carpal tunnel release". | 9 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 1 of those clearances were issued from 2021 to 2025. | 1 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| Acu Med, Inc. holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Acufex Microsurgical, Inc. holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Davol, Inc. holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Kinetix Instruments holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Orthomet, Inc. holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Rafael Medical Devices, Llc holds 1 510(k) clearances for devices named "carpal tunnel release". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 260 papers mentioning "carpal tunnel release" in the title or abstract in 2025. | 260 papers | 2025 | U.S. National Library of Medicine |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 1
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 2
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 3
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 1
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339112, 2025 (2026-11-04)
Quoted lines
- Figure 4
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_estabs 4547
- Figure 5
QCEW 2025 annual, US000, private, NAICS 339112, annual_avg_emplvl 140413
- Figure 6
QCEW 2020 annual_avg_emplvl 135655; 2025 annual_avg_emplvl 140413
- Figure 7
QCEW 2025 annual, US000, private, NAICS 339112, avg_annual_pay 109475
- Figure 4
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "carpal tunnel release" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"carpal tunnel release", sum of counts by decision_date = 9
- Figure 9
openFDA device/510k decision_date 2021-2025 count = 1
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "carpal tunnel release" (2026-11-04)
Quoted lines
- Figure 10
applicant.exact "Acu Med, Inc." count 1
- Figure 11
applicant.exact "Acufex Microsurgical, Inc." count 1
- Figure 12
applicant.exact "Davol, Inc." count 1
- Figure 13
applicant.exact "Kinetix Instruments" count 1
- Figure 14
applicant.exact "Orthomet, Inc." count 1
- Figure 15
applicant.exact "Rafael Medical Devices, LLC" count 1
- Figure 10
- U.S. National Library of Medicine: PubMed search "carpal tunnel release"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 16
esearch count 260
- Figure 16
Buyers and suppliers
Who buys
- Hospitals
- Ambulatory surgery centers
- Orthopedic and hand surgeons
Companies to watch
Acu Med, Inc.
1 FDA 510(k) clearances for devices named "carpal tunnel release".
Acufex Microsurgical, Inc.
1 FDA 510(k) clearances for devices named "carpal tunnel release".
Davol, Inc.
1 FDA 510(k) clearances for devices named "carpal tunnel release".
Kinetix Instruments
1 FDA 510(k) clearances for devices named "carpal tunnel release".
Orthomet, Inc.
1 FDA 510(k) clearances for devices named "carpal tunnel release".
Rafael Medical Devices, Llc
1 FDA 510(k) clearances for devices named "carpal tunnel release".
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 United States 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
- Written to order in 5 working days
Frequently asked questions
How many carpal tunnel release systems devices are cleared by the FDA?
openFDA lists 9 510(k) clearances for devices named carpal tunnel release.
Which companies hold the most FDA clearances for carpal tunnel release systems?
By 510(k) count: Acu Med, Inc., Acufex Microsurgical, Inc., Davol, Inc., Kinetix Instruments.
How many US companies are in the carpal tunnel release systems industry?
BLS counts 4,547 private establishments in NAICS 339112 (Surgical and medical instrument manufacturing), the closest official industry.
How many EU companies are in the carpal tunnel release systems industry?
Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).
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