510(k) K260975
- Device
- Libertas Acetabular Liners (Acetabular Liner)
- Applicant
- Maxx Orthopedics, Inc.
- 510(k) number
- K260975
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-29
- Date received
- 2026-03-24
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Donald Guthner
- Address
- 2460 General Armistead Ave. Norristown PA US 19403 19403
FDA Registration Numbers#
- 1038671
- 3007189546
- 3006085220
- 3005751028
- 3001278222
- 1649518
- 3003998208
- 3015978338
- 2249615
- 3012319330
- 3008572101
- 3009546990
- 3014302784
- 1644408
- 9616671
- 1226544
- 3010536692
- 1722511
- 3002807090
- 3013014058
- 3004641308
- 2245304
- 3004635447
- 3002806470
- 3025603301
- 3033509898
- 3004748528
- 3042508254
- 3009959868
- 3007311878
- 1828288
- 1000550978
- 3012329926
- 1836357
- 3005360851
- 2134285
- 1721676
- 3005061536
- 1526534
- 1833920
- 3010097171
- 3013450937
- 3006128100
- 3007913880
- 3011277306
- 3010468876
- 3014644608
- 3009882462
- 9681642
- 3005581234
- 3009173317
- 3010120135
- 3006017180
- 1833986
- 3010041693
- 2648920
- 3009973505
- 3009760038
- 3008395353
- 3018094310
- 8010916
- 3009998573
- 3008021110
- 3009973336
- 1220246
- 1219655
- 3008556682
- 3000931034
- 1720929
- 3015542154
- 3006946279
- 9614209
- 3002806603
- 1531174
- 1000547811
- 8044172
- 3010173425
- 1018470
- 9616680
- 3020967480
Source Documents#
Other 510(k) Records For Product Code JDI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 |