510(k) · Cleared
Recalled · Class II · 2025Comprehensive Shoulder System
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 Oct 28, 2020 as substantially equivalent to K060692 (Biomet Manufacturing Corp, 2006) after a 363-day review. Its family tree reaches back 5 generations to 1980. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 28, 2020
- Review
- 363 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K800494 (1980). 25 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 1 generation backK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- This deviceK193038 Comprehensive Shoulder SystemBiomet Manufacturing Corp · 2020
- Descendant · cites it directly · 4 of its ownK213856 Identity Shoulder SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK214001 Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp · 2023
- Descendant · 2 generations on · 0 of its ownK252404 Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics · 2026
- Descendant · 3 generations on · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213856Identity Shoulder SystemZimmer, Inc. · 2022 · cites it directly4descendants
- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · 2 generations on1descendant
- K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp · 2023 · cites it directly1descendant
- K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics · 2026 · 2 generations on0descendants
- K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −1 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| 0 (this device) | K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020 | — |
| +1 | K213856 | Identity Shoulder System | Zimmer, Inc. | 2022 | — |
| +2 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +1 | K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Biomet Manufacturing Corp | 2023 | — |
| +2 | K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026 | — |
| +3 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 4…Primary Predicate 510(k) Number Comprehensive Primary Shoulder K060692 Reference Predicates 510(k) Number Comprehensive Humeral Fracture… | 2006 |
| † | K033506 | Comprehensive Humeral Fracture Positioning Sleeve | 2004 |
| † | K040610 | Versa-Dial Humeral Head | 2004 |
| † | K060694 | Modular Hybrid Glenoid | 2006 |
| † | K060716 | Versa-Dial Humeral Head Prosthesis | 2006 |
| † | K140390 | Titanium Versa-Dial Humeral Head Prosthesis | 2014 |
| † | K140652 | Porous Coated Comprehensive Fracture Stems | 2014 |
What descends from it? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2025 | Class II | Z-1403-2025 | Nonconforming Material/Component | Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 25 ancestors have a recall of any class.
- Of its descendants, K213856 (Zimmer, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 14 other devices also cite its predicate K060692.
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. 2020, this device’s year, is highlighted.
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?
1 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision in some medical conditions (e. g0…
Read the full statement (230 words)
1 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision in some medical conditions (e. g0 revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure
Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
The Comprehensive Hurneral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193038: Comprehensive 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/K193038
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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