Panels › Orthopedic › Product code KWA · Class 3
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation 888.3330
0510(k)s in 12 months (114 all time)
0recalls in 12 months (203 all time)
198recalls that name a 510(k)
Top companies in KWA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178570 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178568 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178566 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178565 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178564 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178562 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178560 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
joint replacement
Item Number: 178558 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178556 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178554 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Item Number: 178552 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178414 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178412 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178410 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178408 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178406 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178404 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178402 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178400 Open, Classified |
KWA | K062998 |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030 Open, Classified |
KWA | K052320 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM
Item Number: 11-301354 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM
Item Number: 11-301343 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM
Item Number: 11-301342 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM
Item Number: 11-301335 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM
Item Number: 11-301333 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM
Item Number: 11-301331 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM
Item Number:11-301325 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM
Item Number: 11-301322 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM
Item Number: 11-301321 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM
Item Number:
11-301315 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM
Item Number: 11-301314 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM
Item Number: 11-301312 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM
Item Number: 11-301311 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM
Item Number: 11-301310 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM
Item Number: 11-301302 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM
Item Number: 11-301301 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM
Item Number: 11-301300 Terminated |
KWA | K090757 |
| Dec 15, 2020 | DePuy Orthopaedics, Inc. Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 12 Terminated |
KWA | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Metasul Femoral Heads, various sizes, Item Nos. 00877004001
00877004002
00877004003
00877004004
00877004005 Terminated |
KWA | K091973 |
| Oct 10, 2019 | Zimmer Biomet, Inc. Metasul Taper Liner, various sizes, Item Nos. 00877000528
00877000628
00877000732
00877000832
00877000936
00877001036
00877001140
00877001240
00877001340
00877001440
00877001540
00877001640
0087700174 Terminated |
KWA | K091973 |
| Oct 12, 2018 | Zimmer Biomet, Inc. Zimmer Compress Devices and Instruments:
Item Number/Item Description
178350 Compress Device Anti-Rotation Spindle
178353 Compress Device Anti-Rotation Spindle
178356 Compress Device Anti-Rotation Spi Terminated |
KWA | K112905 |
| Jun 8, 2018 | Zimmer Biomet, Inc. ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem Terminated |
KWA | K070274 |
| Jun 5, 2017 | Zimmer Biomet, Inc. ECHO POR FMRL NC 9X125, model # 192009 Terminated |
KWA | K070274 |
| Feb 11, 2017 | Encore Medical, Lp LIMA Modular Revision Hip Stem Model 428-01-050_110
Product Usage:
The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized d Terminated |
KWA | K092331 |
| Feb 22, 2016 | Zimmer Biomet, Inc. Metasul Head 40, 12/14, SZ M/0
total hip prosthesis - metal femoral heads
Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and Terminated |
KWA | K091973 |
| Jun 8, 2015 | Zimmer, Inc. M/L Taper with Kinectiv Technology.
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Product Usage: Usage:
Total hip replacement for the following: severe hip pain and disab Terminated |
KWA | K071856 |
| Feb 20, 2015 | Zimmer Gmbh Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease. Terminated |
KWA | K974728 |
| Feb 20, 2015 | Zimmer Gmbh Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. Terminated |
KWA | K033634 |
| Feb 17, 2015 | Biomet, Inc. Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. Terminated |
KWA | K093235 |
| Jul 21, 2014 | DePuy Orthopaedics, Inc. RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal St Terminated |
KWA | K102080 |
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