510(k) · Cleared
ClearedSelect Shoulder Curved-Back Pegged All Poly Glenoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Feb 27, 1997 after a 14-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 27, 1997
- Review
- 14 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Select Shoulder Pegged All-Poly Glenoids Named without a submission number | |
| * | — | Select Shoulder Keeled All-Poly Glenoids Named without a submission number | |
| * | — | Glenoids used in the Orthomet/3M Modular Neer II Shoulder System Named without a submission number | |
| * | — | Glenoids used in the Zimmer Fenlin Total Shoulder Named without a submission number | |
| * | — | Glenoids used in the Smith & Nephew Richards Cofield Shoulder Named without a submission number | |
| * | — | Glenoids used in the Kirschner/Biomet Modular Shoulder Named without a submission number | |
| * | — | Glenoids used in the Biomet Bio-Modular Total Shoulder Named without a submission number | |
| * | — | Glenoids used in the Depuy Global Total Shoulder System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970567: Select Shoulder Curved-Back Pegged All Poly Glenoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970567
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026