# K970567: Select Shoulder Curved-Back Pegged All Poly Glenoids

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Feb 27, 1997 after 14 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Select Shoulder Pegged All-Poly Glenoids: named in the summary without a submission number
- (no number) Select Shoulder Keeled All-Poly Glenoids: named in the summary without a submission number
- (no number) Glenoids used in the Orthomet/3M Modular Neer II Shoulder System: named in the summary without a submission number
- (no number) Glenoids used in the Zimmer Fenlin Total Shoulder: named in the summary without a submission number
- (no number) Glenoids used in the Smith & Nephew Richards Cofield Shoulder: named in the summary without a submission number
- (no number) Glenoids used in the Kirschner/Biomet Modular Shoulder: named in the summary without a submission number
- (no number) Glenoids used in the Biomet Bio-Modular Total Shoulder: named in the summary without a submission number
- (no number) Glenoids used in the Depuy Global Total Shoulder System: named in the summary without a submission number

## Indications for use
The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following: Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (UD), e.g., theumatoid arthritis. Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty. Avascular necrosis or osteonecrosis of the humeral head. Tumor resection.

Source page: https://510kreport.com/device/K970567
Methodology: https://510kreport.com/methodology