Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution
FDA 510(k) K031449 · Implex Corp.
510(k) numberK031449
Submission
- Device name
- Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- May 7, 2003
- Decision date
- September 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | 11/19/2003SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K032282 | Modification to Hedrocel Trabecular Metal Reconstruction SystemEZX · Special | 08/21/2003SE |
Questions and answers
When was Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution cleared by the FDA?
Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution (K031449) received a 510(k) decision of Substantially Equivalent on September 23, 2003, 139 days after the submission was received.
What is the product code of K031449?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.