510(k) · Cleared
ClearedComprehensive Nano Stemless Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Apr 22, 2019 as substantially equivalent to K143552 (Tornier, Inc., 2015) and 3 other predicates after a 221-day review. Its family tree reaches back 7 generations to 1991. 6 later devices descend from it.
- Decided
- Apr 22, 2019
- Review
- 221 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K911686 (1991). 61 ancestors in all, the oldest K790987 (1979). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 3 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 2 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- 1 generation backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- This deviceK182516 Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019
- Descendant · cites it directly · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · cites it directly · 1 of its ownK241873 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK262955 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243248 Inhance Intact™Depuy Ireland UC · 2024
- Descendant · 2 generations on · 0 of its ownK230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE…Depuy Ireland UC · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
- K241873OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024 · cites it directly1descendant
- K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026 · 2 generations on0descendants
- K243248Inhance Intact™Depuy Ireland UC · 2024 · 2 generations on0descendants
- K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −3 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −2 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| −1 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| 0 (this device) | K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 | — |
| +1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +1 | K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024 | — |
| +2 | K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2026 | — |
| +2 | K243248 | Inhance Intact™ | Depuy Ireland UC | 2024 | — |
| +2 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…joint metal/polymer semi-constrained cemented prosthesis (21 CFR § 888.3660) Predicate Devices: K143552 Simpliciti Shoulder Wright Medical (formerly System… | 2015 |
| * | K171858 | Sidus Stem-Free ShoulderSummary page 4…ystem Tornier) (Primary Predicate) K171858 Sidus Stem-Free Shoulder Zimmer GmbH K173388 Equinoxe Stemless Exactech… | 2017 |
| * | K173388 | Exactech Equinoxe Stemless ShoulderSummary page 4…Predicate) K171858 Sidus Stem-Free Shoulder Zimmer GmbH K173388 Equinoxe Stemless Exactech Shoulder… | 2018 |
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 4…K173388 Equinoxe Stemless Exactech Shoulder K060692 Comprehensive Primary Biomet Manufacturing Shoulder… | 2006 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 13 of the 61 ancestors have a recall of any class.
- Of its descendants, K203108 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K143552.
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. 2019, 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?
1. Primary total shoulder arthroplasty.
2. Non-inflammatory degenerative joint disease including osteoarthritis
Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for
uncemented biological fixation applications.
The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may
be inserted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182516: Comprehensive Nano Stemless Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182516
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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