510(k) K240639
- Device
- PINNACLETM Constrained Acetabular Liners
- Applicant
- Depuy Ireland UC
- 510(k) number
- K240639
- Product code
- KWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-04
- Date received
- 2024-03-06
- Regulation
- 888.3310
- Classification name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jennifer Hill
- Address
- Loughbeg Ringaskiddy Ringaskiddy Cork GB
FDA Registration Numbers#
- 3014302784
- 3007120646
- 1424263
- 3010314800
- 3010220595
- 3035366890
- 1000577893
- 1825034
- 3015207155
- 3010009693
- 3014252644
- 3005180920
- 3007913880
- 3010178296
- 9616944
- 3008102042
- 3000264985
- 3010206549
- 3012319330
- 3038503932
- 2242737
- 1043653
- 3005913274
- 2249697
- 3010057495
- 3008812251
- 3005551626
- 3013014058
- 3010287737
- 3013176080
- 3004748528
- 3008868758
- 3015542154
- 3004641308
- 9681465
- 3025603301
- 9613369
- 2246552
- 1018470
- 3010537287
- 1526534
- 3014763043
- 3002807310
- 3002806535
- 3004635447
- 3007353762
- 3027484613
- 1721676
- 3003387384
- 3002806470
- 1833986
- 3010173425
- 3009888740
- 1531174
- 1835251
- 1835831
- 3012275107
- 3009173317
- 3010386387
- 1818910
- 3011277306
- 3026771806
- 2249615
- 3008110533
- 3009871135
- 3002807315
- 1450662
- 3005323511
- 3010163695
- 3012392319
- 2648920
- 3000196378
- 1529009
- 3001278222
- 3010065126
- 1649518
- 3004153896
- 9610726
- 1828288
- 3012725451
Source Documents#
Other 510(k) Records For Product Code KWZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241461 | Mpact Constrained Liner | Medacta International S.A. | 2025-07-31 |
| K162641 | Smith & Nephew, Inc. R3™ Constrained Liner | Smith & Nephew, Inc. | 2017-06-19 |
| K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | Encore Medical L.P. | 2017-03-02 |
| K161610 | EXPRT Revision Hip System | Encore Medical L.P. | 2016-11-09 |
| K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | Smith & Nephew, Inc. | 2012-10-16 |
| K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | Smith & Nephew, Inc. | 2011-09-09 |
| K101730 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS | Zimmer, Inc. | 2010-12-03 |
| K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | Smith & Nephew, Inc. | 2009-03-03 |
| K072121 | TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER | Zimmer, Inc. | 2008-01-07 |
| K071059 | DEPUY SPA POROUS COATED PROXIMAL SLEEVE | DePuy Orthopaedics, Inc. | 2007-11-09 |
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | Exactech, Inc. | 2007-07-19 |
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER | Zimmer, Inc. | 2007-07-13 |
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2007-05-18 |
| K063552 | SERIES II CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |
| K063550 | SYSTEM 12 CONSTRAINED ACETABULAR LINERS | Howmedica Osteonics Corp. | 2007-03-08 |