Flower Small and Medium Bone Implants

510(k) K123562

Flower Small and Medium Bone Implants is a medical device (FDA Class II; FDA product code HRS, Plate, Fixation, Bone) made by Flower Orthopedics Corporation, cleared under FDA 510(k) K123562 on 29 Mar 2013, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K123562↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK123562	Date29 Mar 2013Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K123562

Recalls

2 recalls · FDA

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

3 dated events

29 Mar 2013 Cleared FDA 510(k) K123562
16 Feb 2015 Recall initiated FDA recalls Z-1314-2015
3 Sep 2021 Recall initiated FDA recalls Z-0034-2022

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K123562
FDA product code: HRS

Device class: Class II
Regulation: 21 CFR Part 888.3030
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Devices cleared under K123562

385 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K123562
		UDI-DI	Size and differences
1.0mm H&F H-Plate, 4x2 Holes, 1.5mm/2.0mm/2.4mm FHF 360 FLOWER ORTHOPEDICS CORPORATION	FHF 360	00840118102308	Height 1 mm	On the market
1.0mm H&F L-Plate (L), 6 Holes, 1.5mm/2.0mm/2.4mm FHF 325 FLOWER ORTHOPEDICS CORPORATION	FHF 325	00840118102230	Height 1 mm	On the market
1.0mm H&F L-Plate (R), 6 Holes, 1.5mm/2.0mm/2.4mm FHF 320 FLOWER ORTHOPEDICS CORPORATION	FHF 320	00840118102223	Height 1 mm	On the market
1.0mm H&F Oblique T-Plate (R), 6 Holes, 1.5mm/2.0mm/2.4mm FHF 330 FLOWER ORTHOPEDICS CORPORATION	FHF 330	00840118102247	Height 1 mm	On the market
1.0mm H&F Straight Plate, 6 Holes, 1.5mm/2.0mm/2.4mm FHF 306 FLOWER ORTHOPEDICS CORPORATION	FHF 306	00840118102186	Height 1 mm	On the market
1.0mm H&F T-Plate, 6 Holes, 1.5mm/2.0mm/2.4mm FHF 340 FLOWER ORTHOPEDICS CORPORATION	FHF 340	00840118102261	Height 1 mm	On the market
1.5mm H&F H-Plate, 3x2 Holes, 1.5mm/2.0mm/2.4mm FHF 455 FLOWER ORTHOPEDICS CORPORATION	FHF 455	00840118102469	Height 1.5 mm	On the market
1.5mm H&F Oblique T-Plate (L), 6 Holes, 1.5mm/2.0mm/2.4mm FHF 435 FLOWER ORTHOPEDICS CORPORATION	FHF 435	00840118102421	Height 1.5 mm	On the market
1.5mm H&F T-Plate, 7 Holes, 1.5mm/2.0mm/2.4mm FHF 445 FLOWER ORTHOPEDICS CORPORATION	FHF 445	00840118102445	Height 1.5 mm	On the market
1.5mm Recon Plate, 5 Holes, 1.5mm/2.0mm/2.4mm FHF 705 FLOWER ORTHOPEDICS CORPORATION	FHF 705	00840118102605	Height 1.5 mm	On the market
1.5mm Recon Plate, 7 Holes, 1.5mm/2.0mm/2.4mm FHF 707 FLOWER ORTHOPEDICS CORPORATION	FHF 707	00840118102629	Height 1.5 mm	On the market
1.5mm Recon T-Plate, 9 Holes, 1.5mm/2.0mm/2.4mm FHF 729 FLOWER ORTHOPEDICS CORPORATION	FHF 729	00840118102711	Height 1.5 mm	On the market
2.0mm x 16mm H-Plate, 5 Holes, 1.5mm/2.0mm/2.4mm FHF 936 FLOWER ORTHOPEDICS CORPORATION	FHF 936	00840118102896	Height 1.5 mm	On the market
Distal Radius Plate, Dorsal (R), 11 Holes, FRP 434 FLOWER ORTHOPEDICS CORPORATION	FRP 434	00840118103947	Height 2.0 mm	On the market
Distal Radius Plate, Volar (L), 11 Holes, FRP 444 FLOWER ORTHOPEDICS CORPORATION	FRP 444	00840118103992	Height 2.5 mm	On the market
Distal Radius Plate, Volar (R), 11 Holes FRP 454 FLOWER ORTHOPEDICS CORPORATION	FRP 454	00840118104043	Height 2.5 mm	On the market
K-Wire Kit, Small KWK 001 FLOWER ORTHOPEDICS CORPORATION	KWK 001	00840118101097	—	On the market
Locking Screw, XL, D: 2.4mm x L: 30mm FRS 930 FLOWER ORTHOPEDICS CORPORATION	FRS 930	00840118112215	Length 30 mm; Outer Diameter 2.4 mm	On the market
Locking Screw, XL, D: 2.4mm x L: 8mm FRS 908 FLOWER ORTHOPEDICS CORPORATION	FRS 908	00840118112109	Length 8 mm; Outer Diameter 2.4 mm	On the market
Proximal Humerus Plate, 11 Holes FRP 464 FLOWER ORTHOPEDICS CORPORATION	FRP 464	00840118103138	Height 3.7 mm	On the market
Recon Plate, 14 Holes, FRP 714 FLOWER ORTHOPEDICS CORPORATION	FRP 714	00840118103442	Height 2.5 mm	On the market
Recon Plate, 8 Holes FRP 708 FLOWER ORTHOPEDICS CORPORATION	FRP 708	00840118103404	Height 2.5 mm	On the market
Straight Osteo Plate, 12 Holes, FRP 512 FLOWER ORTHOPEDICS CORPORATION	FRP 512	00840118103220	Height 3.7 mm	On the market
Straight Osteo Plate, 15 Holes FRP 615 FLOWER ORTHOPEDICS CORPORATION	FRP 615	00840118103350	Height 3.7 mm	On the market
Straight Osteo Plate, 15 Holes, FRP 515 FLOWER ORTHOPEDICS CORPORATION	FRP 515	00840118103237	Height 3.7 mm	On the market
Straight Osteo Plate, 4 Holes, FRP 504 FLOWER ORTHOPEDICS CORPORATION	FRP 504	00840118103169	Height 3.7 mm	On the market
Straight Osteo Plate, 6 Holes FRP 506 FLOWER ORTHOPEDICS CORPORATION	FRP 506	00840118103183	Height 3.7 mm	On the market
Straight Osteo Plate, 6 Holes FRP 606 FLOWER ORTHOPEDICS CORPORATION	FRP 606	00840118103305	Height 3.7 mm	On the market
Variable Angle Compression Screw FCS 312 FLOWER ORTHOPEDICS CORPORATION	FCS 312	00840118110204	Length 12 mm; Outer Diameter 3 mm	On the market
Variable Angle Compression Screw FCS 324 FLOWER ORTHOPEDICS CORPORATION	FCS 324	00840118110266	Length 24 mm; Outer Diameter 3 mm	On the market
Variable Angle Compression Screw FCS 410 FLOWER ORTHOPEDICS CORPORATION	FCS 410	00840118110440	Length 10 mm; Outer Diameter 2.4 mm	On the market
Variable Angle Compression Screw FCS 414 FLOWER ORTHOPEDICS CORPORATION	FCS 414	00840118110464	Length 14 mm; Outer Diameter 2.4 mm	On the market
Variable Angle Compression Screw FCS 416 FLOWER ORTHOPEDICS CORPORATION	FCS 416	00840118110471	Length 16 mm; Outer Diameter 2.4 mm	On the market
Variable Angle Compression Screw FCS 510 FLOWER ORTHOPEDICS CORPORATION	FCS 510	00840118110310	Length 10 mm; Outer Diameter 3.5 mm	On the market
Variable Angle Compression Screw FCS 524 FLOWER ORTHOPEDICS CORPORATION	FCS 524	00840118110389	Length 24 mm; Outer Diameter 3.5 mm	On the market
Variable Angle Compression Screw FCS 624 FLOWER ORTHOPEDICS CORPORATION	FCS 624	00840118111393	Length 24 mm; Outer Diameter 4 mm	On the market
Variable Angle Compression Screw FCS 626 FLOWER ORTHOPEDICS CORPORATION	FCS 626	00840118111409	Length 26 mm; Outer Diameter 4 mm	On the market
Variable Angle Locking Peg FDR 116 FLOWER ORTHOPEDICS CORPORATION	FDR 116	00840118110860	Length 16 mm; Outer Diameter 1.8 mm	On the market
Variable Angle Locking Screw FHF 008 FLOWER ORTHOPEDICS CORPORATION	FHF 008	00840118101851	Length 8 mm; Outer Diameter 2 mm	On the market
Variable Angle Locking Screw FHF 011 FLOWER ORTHOPEDICS CORPORATION	FHF 011	00840118109765	Length 14 mm; Outer Diameter 2 mm	On the market
Variable Angle Locking Screw FHF 020 FLOWER ORTHOPEDICS CORPORATION	FHF 020	00840118101912	Length 20 mm; Outer Diameter 2 mm	On the market
Variable Angle Locking Screw FLP 330 FLOWER ORTHOPEDICS CORPORATION	FLP 330	00840118104616	Length 30 mm; Outer Diameter 3.0 mm	On the market
Variable Angle Locking Screw FLP 332 FLOWER ORTHOPEDICS CORPORATION	FLP 332	00840118104654	Length 32 mm; Outer Diameter 3.0 mm	On the market
Variable Angle Locking Screw FLP 350 FLOWER ORTHOPEDICS CORPORATION	FLP 350	00840118104715	Length 50 mm; Outer Diameter 3.0 mm	On the market
Variable Angle Locking Screw FRP 232 FLOWER ORTHOPEDICS CORPORATION	FRP 232	00840118100694	Length 32 mm; Outer Diameter 2.7 mm	On the market
Variable Angle Locking Screw FRP 310 FLOWER ORTHOPEDICS CORPORATION	FRP 310	00840118100793	Length 10 mm; Outer Diameter 3.5 mm	On the market
Variable Angle Locking Screw FRP 324 FLOWER ORTHOPEDICS CORPORATION	FRP 324	00840118100861	Length 24 mm; Outer Diameter 3.5 mm	On the market
Variable Angle Non-Locking Screw FLS 328 FLOWER ORTHOPEDICS CORPORATION	FLS 328	00840118104852	Length 28 mm; Outer Diameter 3.0 mm	On the market
Variable Angle Non-Locking Screw FLS 334 FLOWER ORTHOPEDICS CORPORATION	FLS 334	00840118104883	Length 34 mm; Outer Diameter 3.0 mm	On the market
Variable Angle Non-Locking Screw FLS 340 FLOWER ORTHOPEDICS CORPORATION	FLS 340	00840118104913	Length 40 mm; Outer Diameter 3.0 mm	On the market

Other devices from Flower Orthopedics Corporation

See all devices from Flower Orthopedics Corporation →

Flower Small and Medium Bone Implants

Regulatory status

Recalls

Timeline

Coverage

Specification

Devices cleared under K123562

Other devices from Flower Orthopedics Corporation

Active Compression OC55042

Active Compression OC55040

Active Compression OC55044

Active Compression OC55046

Regulatory status

Recalls

Timeline

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K123562

Other devices from Flower Orthopedics Corporation

Active Compression OC55042

Active Compression OC55040

Active Compression OC55044

Active Compression OC55046