Panels › Orthopedic › Product code KWL · Class 2
Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation 888.3360
3510(k)s in 12 months (108 all time)
1recalls in 12 months (51 all time)
44recalls that name a 510(k)
Top companies in KWL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm
C-M079-2-801
ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID
C-M071-6-700
ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD
C-M071-8- Open, Classified |
KWL | K261624 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-038 Open, Classified |
KWL | K014226 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-042 Open, Classified |
KWL | K014226 |
| Jul 16, 2024 | Howmedica Osteonics Corp. UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty.
Catalog Number: 6942-5-043 Open, Classified |
KWL | K014226 |
| Jun 21, 2018 | DePuy Orthopaedics, Inc. CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 Terminated |
KWL | K042992 K123991 |
| Feb 12, 2018 | DePuy Orthopaedics, Inc. CORAIL HIGH OFFSET STEM Collarless SIZE 14 Terminated |
KWL | None listed |
| Feb 12, 2018 | DePuy Orthopaedics, Inc. CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Terminated |
KWL | None listed |
| Nov 16, 2015 | Smith & Nephew, Inc. BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers:
74121238, MODULAR HEAD 38 MM -8MM
74121242, MODULAR HEAD 42 MM -8MM
74121246, MODULAR HEAD 46 MM -8MM
74121250, MODULAR HEAD 50 MM -8MM
74121 Terminated |
KWL | K061243 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants.
Stryker Orthopaedics.
Indicated for use in partial hip rep Terminated |
KWL | K071471 |
| Jul 22, 2009 | Stryker Howmedica Osteonics Corp. Omniflex-HA Hip Stem W/C Taper.
Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a p Terminated |
KWL | K920193 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Mar 20, 2008 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430 Terminated |
KWL | K800207 |
| Jan 13, 2007 | Stryker Howmedica Osteonics Corp. Howmedica Hip Fracture Stem System
No. 4 Femoral Component
Fenestrated
Sterile REF Catalogue #6942-0-040
Made in Ireland Terminated |
KWL | None listed |
| Jan 13, 2007 | Stryker Howmedica Osteonics Corp. Howmedica Hip Fracture Stem System
No. 3.5 Femoral Component
Uses No. 3 Fenestrated Plus
Sterile REF Catalogue #6942-0-035
Made in Ireland Terminated |
KWL | None listed |
| Jan 13, 2007 | Stryker Howmedica Osteonics Corp. Howmedica Hip Fracture Stem System
No. 3 Femoral Component
Fenestrated
Sterile REF Catalogue #6942-0-030
Made in Ireland Terminated |
KWL | None listed |
| Jan 13, 2007 | Stryker Howmedica Osteonics Corp. Howmedica Hip Fracture Stem System
No. 2 Femoral Component
Fenestrated
Sterile REF Catalogue #6942-0-020
Made in Ireland Terminated |
KWL | None listed |
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