510(k) · Cleared
ClearedOsseoFit Stemless Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Sep 24, 2026 as substantially equivalent to K241873 (Zimmer, Inc., 2024) after a 31-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Sep 24, 2026
- Review
- 31 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911686 (1991). 63 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- 2 generations backK182516 Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019
- 1 generation backK241873 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
- This deviceK262955 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 5 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 4 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- 3 generations backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- 2 generations backK182516 Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019
- 1 generation backK241873 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
- This deviceK262955 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −5 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −4 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| −3 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| −2 | K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 | — |
| −1 | K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024 | — |
| 0 (this device) | K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 4 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 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.
Planning a device in PKC? 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 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? (1)
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 |
|---|---|---|---|
| * | K241873 | OsseoFit Stemless Shoulder SystemSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I 1<241873 11 OsseoFit Stemless Shoulder System… | 2024 |
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.
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 13 of the 63 ancestors have a recall of any class.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Anatomic Total Shoulder Applications:
• Osteoarthritis
• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.
OsseoFit® Stemless Shoulder humeral components have a porous surface and are indicated for
uncemented biological fixation applications
Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be
inserted without bone cement.
Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the
addition of screw fixation.
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/K262955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262955: OsseoFit Stemless Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262955
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026