510(k) · Cleared
Recalled · Class II · 2020Comprehensive Primary Shoulder Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on May 30, 2006 as substantially equivalent to K030710 (Biomet, Inc., 2003) and 2 other predicates after a 76-day review. Its family tree reaches back 4 generations to 1980. 138 later devices descend from it. It has been recalled 6 times.
- Decided
- May 30, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 4 generations to K800494 (1980). 24 ancestors in all. 138 later devices descend from it, 15 citing it directly.
- Root · 4 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 3 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 2 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 1 generation backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- This deviceK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · cites it directly · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 2 generations on · 97 of its ownK121493 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · cites it directly98descendants
- K121493Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on97descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −3 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −2 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| 0 (this device) | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | — |
| +1 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +1 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +2 | K121493 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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 MBF? 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K030710 | Bio-Modular Shoulder SystemSummary page 1…nted Prosthesis (21 CFR §888.3690) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: *Bio-Modular® Shoulder System; Biomet Manufacturing Corp. (K(030710) *Comprehensive® Humneral Fracture Stems; Biomet Manufacturing Corp. (K023063) *Integrated TM Shoulder System (Kirschner Sh… | 2003 |
| * | K023063 | Comprehensive Humeral Fracture SystemSummary page 1…l Equivalence Is Claimed: *Bio-Modular® Shoulder System; Biomet Manufacturing Corp. (K(030710) *Comprehensive® Humneral Fracture Stems; Biomet Manufacturing Corp. (K023063) *Integrated TM Shoulder System (Kirschner Shoulders with Titanium Plasma Spray); Biomet, Inc. (K(961260) Device Descrip… | 2002 |
| * | K961260 | Kirschner Sholders with Titanium Plasma SpraySummary page 1…e® Humneral Fracture Stems; Biomet Manufacturing Corp. (K023063) *Integrated TM Shoulder System (Kirschner Shoulders with Titanium Plasma Spray); Biomet, Inc. (K(961260) Device Description: The Comprehensive® Primary Shoulder Stems are humeral stems comprised of titanium alloy. The stems are avai… | 1997 |
What descends from it? (138)
See all 13815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102924 | Aequalis Ascend Modular Anatomic Shoulder System | 2011 | 110 |
| K120794 | Ascend Shoulder System | 2012 | 98 |
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
| K191963 | SMR Finned Short Stems | 2019 | 13 |
| K212737 | INHANCE™ Reverse Shoulder System | 2022 | 9 |
| K193038 | Comprehensive Shoulder System | 2020 | 8 |
| K182516 | Comprehensive Nano Stemless Shoulder | 2019 | 6 |
| K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | 2014 | 4 |
| K131633 | Arthrex Univers Apex | 2013 | 4 |
| K173824 | Humeral Short Stem System | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2020 | Class II | Z-1543-2020 | Under Investigation by firm | A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. |
| Oct 10, 2018 | Class II | Z-0591-2019 | Under Investigation by firm | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as… |
| Dec 8, 2017 | Class II | Z-0980-2018 | Under Investigation by firm | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two… |
| Dec 8, 2017 | Class II | Z-0979-2018 | Under Investigation by firm | Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two… |
| Jun 5, 2017 | Class II | Z-0299-2018 | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. |
| Apr 16, 2015 | Class III | Z-1755-2015 | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K102924 (Tornier, Inc., 2011) has gone furthest, with 110 descendants of its own.
- 19 other devices also cite its predicate K030710.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Comprehensive® Primary Shoulder Stems are intended for heml or total shoulder replacement: 1) Non-Inflammatory degenerative joint disease, including osteoarthritls and avascular necrosis. 2) Rheumatoid arthritis. 3) Revision where other devices or treatments have failed. 4) Correction of functional deformity. 5) Fractures of the proximal humerus where other methods of treatment are deemed inadequate. 6) Difficult clinical management problems…
Read the full statement (132 words)
The Comprehensive® Primary Shoulder Stems are intended for heml or total shoulder replacement:
1) Non-Inflammatory degenerative joint disease, including osteoarthritls and avascular necrosis.
2) Rheumatoid arthritis.
3) Revision where other devices or treatments have failed.
4) Correction of functional deformity.
5) Fractures of the proximal humerus where other methods of treatment are deemed inadequate.
6) Difficult clinical management problems, Including cuff tear aithropathy, where other methods of treatment may not be suitable or may be Inadequate.
Humeral/glenold components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenold components offer optional screw fixation.)
The Comprehensive® Primary Shoulder Stems are intended for use only with the Bio-Modular® humeral heads and glenoid components and the Versa-Dial TM humeral head components.
The devices are single-use Implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060692: Comprehensive Primary Shoulder Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060692
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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