510(k) · Cleared
ClearedSelect Shoulder Cocr Humeral Stem Component
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 Sep 3, 1996 after a 78-day review. The FDA summary names its predicate without a number. 1 of the 336 devices in its family, counting itself, has a Class I recall. 335 later devices descend from it.
- Decided
- Sep 3, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 0
335 later devices descend from it, 2 citing it directly. 1 of the 336 devices in this family, counting this one, has a Class I recall.
- This deviceK962315 Select Shoulder Cocr Humeral Stem ComponentIntermedics Orthopedics · 1996
- Descendant · cites it directly · 259 of its ownK041339 Aequalis Shoulder SystemTornier · 2004
- Descendant · 2 generations on · 258 of its ownK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- Descendant · 2 generations on · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- Descendant · cites it directly · 235 of its ownK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 218 of its ownK041549 Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · Recalled
Showing 5 of 335 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations on · 2008
Most influential descendants
Showing 5 of 335 · See all- K041339Aequalis Shoulder SystemTornier · 2004 · cites it directly259descendants
- K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier · 2004 · 2 generations on258descendants
- K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · 2 generations on257descendants
- K982981New Zimmer Shoulder SystemZimmer, Inc. · 1998 · cites it directly235descendants
- K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · 2 generations on218descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962315 | Select Shoulder Cocr Humeral Stem Component | Intermedics Orthopedics | 1996 | — |
| +1 | K041339 | Aequalis Shoulder System | Tornier | 2004 | — |
| +2 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| +2 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| +1 | K982981 | New Zimmer Shoulder System | Zimmer, Inc. | 1998 | 1 |
| +2 | K041549 | Zimmer Trabecular Metal Humeral Stem | Zimmer, Inc. | 2004 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 1 |
| 2010 | 8 | 0 |
| 2011 | 16 | 0 |
| 2012 | 14 | 0 |
| 2013 | 15 | 0 |
| 2014 | 12 | 0 |
| 2015 | 8 | 0 |
| 2016 | 13 | 0 |
| 2017 | 18 | 0 |
| 2018 | 22 | 0 |
| 2019 | 24 | 0 |
| 2020 | 23 | 0 |
| 2021 | 28 | 0 |
| 2022 | 23 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 27 | 0 |
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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | — | Depuy Global Total Shoulder System Named without a submission number | |
| * | — | Biomet Bio-Modular Total Shoulder Named without a submission number | |
| * | — | Zimmer Fenlin Total Shoulder Named without a submission number | |
| * | — | Kirschner Integrated Shoulder System Named without a submission number | |
| * | — | 3M/Orthomet Neer I Shoulder System Named without a submission number | |
| * | — | Smith & Nephew Richards Cofield Shoulder Named without a submission number |
What descends from it? (335)
See all 3352 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041339 (Tornier, 2004) has gone furthest, with 259 descendants of its own.
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 humeral component is intended for use with bone cement in total shoulder arthroplasty.
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/K962315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962315: Select Shoulder Cocr Humeral Stem Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962315
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026