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Variable Angle Locking Peg FDR 116

by Flower Orthopedics Corporation

Variable Angle Locking Peg FDR 116 is an orthopaedic bone screw (FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Flower Orthopedics Corporation, cleared under FDA 510(k) K123562 on 29 Mar 2013 and listed in FDA GUDID since 15 Sep 2015 (UDI-DI 00840118110860), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K123562

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840118110860 UDI-DI Date15 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123562 Date29 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123562 decided 29 Mar 2013 Active
  • FDA GUDID UDI-DI 00840118110860 listed 15 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0034-2022 FDA Class II initiated 3 Sep 2021 on shared 510(k) K123562

    Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

    • Terminated Z-1314-2015 FDA Class II initiated 16 Feb 2015

    Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K123562
  2. Recall initiated FDA recalls Z-1314-2015
  3. Listed FDA GUDID 00840118110860
  4. Recall initiated FDA recalls Z-0034-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Variable Angle Locking Peg
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / reference
FDR 116
Primary DI / UDI-DI
00840118110860
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Size
Length — 16 Millimeter
Outer Diameter — 1.8 Millimeter

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K123562)

and 8 more cleared under K123562

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, sterile.

Other devices from Flower Orthopedics Corporation

See all devices from Flower Orthopedics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)