510(k) K181569
- Device
- BKS Revision Sleeves System
- Applicant
- Ortho Development Corporation
- 510(k) number
- K181569
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-12
- Date received
- 2018-06-14
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dan Petersen
- Address
- 12187 So. Business Park Dr. Draper UT US 84020 84020
FDA Registration Numbers#
- 2249615
- 3012392319
- 3014273644
- 3013176080
- 3006849754
- 3013843055
- 3026771806
- 3010057495
- 3010468876
- 3010386387
- 3012523063
- 3010123256
- 3008285983
- 3009998573
- 3003916006
- 3003387384
- 3004450489
- 3019006180
- 3015167917
- 3016096064
- 3008021110
- 3015542154
- 1724955
- 1000200989
- 3005596372
- 3009882462
- 2648920
- 3005874553
- 2531477
- 3011187779
- 2183744
- 3006395932
- 3002806603
- 3008102042
- 1423662
- 3007963827
- 3003541440
- 3007334927
- 3000236920
- 3006694268
- 3010155661
- 3011170410
- 1018470
- 3004976965
- 3013055499
- 2134947
- 3009973505
- 2245304
- 3006356043
- 3010178296
- 3013186738
- 3015806723
- 3025603301
- 3008824097
- 3014763043
- 1064858
- 3015398319
- 1061927
- 3015231789
- 3006015326
- 3006406161
- 3011061242
- 3013194153
- 3005551626
- 9616671
- 3016470314
- 3006801265
- 3007189546
- 3005652161
- 1835251
- 3017410889
- 3000264985
- 1000547811
- 1834331
- 3005751028
- 3009475821
- 3007539489
- 3017397663
- 3009241418
- 9616680
Source Documents#
Other 510(k) Records For Product Code JWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262057 | GMK Extension | Medacta International SA | 2026-09-15 |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026-09-11 |
| K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-09-10 |
| K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | 2026-09-08 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | 2026-09-04 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026-09-01 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | 2026-07-31 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 |
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | 2025-11-19 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 |
Legacy Summary#
summary
FDA Review#
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