Trigen 71633425

• FDA 510(k) K210980 decided 14 Nov 2022 Active· +1 more in the status table
• FDA GUDID UDI-DI 03596010406002 listed 30 Aug 2015 Listed

• • Ongoing Z-2456-2026 FDA Class II ·initiated 16 Mar 2026 ·on shared 510(k) K210980

  Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.

• • Ongoing Z-1806-2025 FDA Class II ·initiated 18 Mar 2025 ·on shared 510(k) K210980

  Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

• 2 recalls, same reason

  • Ongoing Z-2444-2023 FDA Class II ·initiated 24 Jul 2023 ·on shared 510(k) K210980
  • Ongoing Z-2443-2023 FDA Class II ·initiated 24 Jul 2023 ·on shared 510(k) K210980

  A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

• 2 recalls, same reason

  • Terminated Z-0944-2013 FDA Class II ·initiated 7 Feb 2013
  • Terminated Z-0943-2013 FDA Class II ·initiated 7 Feb 2013

  75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 9 Jul 1998 Cleared FDA 510(k) K981529
2. 7 Feb 2013 Recall initiated FDA recalls Z-0944-2013
3. 7 Feb 2013 Recall initiated FDA recalls Z-0943-2013
4. 30 Aug 2015 Listed FDA GUDID 03596010406002
5. 14 Nov 2022 Cleared FDA 510(k) K210980
6. 24 Jul 2023 Recall initiated FDA recalls Z-2444-2023
7. 24 Jul 2023 Recall initiated FDA recalls Z-2443-2023
8. 18 Mar 2025 Recall initiated FDA recalls Z-1806-2025
9. 16 Mar 2026 Recall initiated FDA recalls Z-2456-2026

Trade name

Trigen

Generic name

Tibia intramedullary nail

Model / Ref / Catalog

71633425

Primary DI / UDI-DI

03596010406002

510(k) Number

K210980 ↗

K981529 ↗

FDA product code

JDS

GMDN term

Tibia intramedullary nail

Device class

Class II

Regulation number

888.3030

GUDID distribution status

In Commercial Distribution

Category: Tibia intramedullary nail

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

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