Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K220838Substantially equivalent (SESE) · 2022-05-20clearance family
Predicate lineage
- K220838
- K153345
- K003379
- K003391
- K010170
- K010757
- K011623
- K013676
- K014226
- K020497
- K020572
- K021310
- K021911
- K022077
- K022555
- K023102
- K023901
- K031730
- K031744
- K033716
- K040412
- K041170
- K041940
- K051588
- K051737
- K051738
- K051741
- K052718
- K061434
- K061654
- K062419
- K070885
- K072020
- K081171
- K093644
- K102019
- K103233
- K103479
- K110290
- K120578
- K121308
- K122853
- K123604
- K142462
- K143085
- K151264
- K894124
- K900836
- K902365
- K903362
- K910988
- K920868
- K942809
- K943549
- K954077
- K971409
- K983226
- K983382
- K983502
- K991952
- K992570
- K993601
- K994366
- P960047
- K914406
- K924323
- K951860
- K153345
Cited as predicate by: K233498
K951860
Cited as predicate by: K220838
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2021-06-22 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
| 2015-03-09 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2013-04-16 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2010-01-15 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
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