510(k) · Cleared
Recalled · Class II · 2017Modular Hybrid Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Dec 11, 2006 as substantially equivalent to K030710 (Biomet, Inc., 2003) and 6 other predicates after a 271-day review. Its family tree reaches back 4 generations to 1980. 57 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 11, 2006
- Review
- 271 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 4
- Predicates
- 7
Its longest line of descent runs back 4 generations to K800494 (1980). 26 ancestors in all. 57 later devices descend from it, 6 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 deviceK060694 Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006
- Descendant · cites it directly · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- Descendant · cites it directly · 23 of its ownK091196 GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009
- Descendant · 2 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 20 of its ownK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · cites it directly24descendants
- K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009 · cites it directly23descendants
- K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 2 generations on22descendants
- K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 3 generations on21descendants
- K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc. · 2012 · 4 generations on20descendants
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) | K060694 | Modular Hybrid Glenoid | Biomet Manufacturing Corp | 2006 | — |
| +1 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| +1 | K091196 | GRS Glenoid Resurfacing System | Arthrosurface, Inc. | 2009 | — |
| +2 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| +3 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| +4 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 9 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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…tal/Polymer, Cemented (21 CFR Section 888.3660) Legally Marketed Device to which Substantial Equivalence Is claimed: * Bio-ModularlD Shoulder System (Biomet) K030710, K992119 7 * The Trabecular Metal Glenoid (Zimmer) M… | 2003 |
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…er, Cemented (21 CFR Section 888.3660) Legally Marketed Device to which Substantial Equivalence Is claimed: * Bio-ModularlD Shoulder System (Biomet) K030710, K992119 7 * The Trabecular Metal Glenoid (Zimmer) M… | 1999 |
| * | K043061 | The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model…Summary page 1…met) K030710, K992119 7 * The Trabecular Metal Glenoid (Zimmer) M K043061, K031449, K022377 * DePuy Global TM Shoulder Glenoid (DePuy) K052472, K981487 Device Description: The Modular Hybrid Gleno… | 2004 |
| * | K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…Summary page 1…K030710, K992119 7 * The Trabecular Metal Glenoid (Zimmer) M K043061, K031449, K022377 * DePuy Global TM Shoulder Glenoid (DePuy) K052472, K981487 Device Description: The Modular Hybrid Glenoid consis… | 2003 |
| * | K022377 | The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306Summary page 1…710, K992119 7 * The Trabecular Metal Glenoid (Zimmer) M K043061, K031449, K022377 * DePuy Global TM Shoulder Glenoid (DePuy) K052472, K981487 Device Description: The Modular Hybrid Glenoid consists of a b… | 2002 |
| * | K052472 | Depuy Global Shoulder Crosslink GlenoidSummary page 1…l Glenoid (Zimmer) M K043061, K031449, K022377 * DePuy Global TM Shoulder Glenoid (DePuy) K052472, K981487 Device Description: The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave… | 2005 |
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 1…(Zimmer) M K043061, K031449, K022377 * DePuy Global TM Shoulder Glenoid (DePuy) K052472, K981487 Device Description: The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articula… | 1998 |
What descends from it? (57)
See all 576 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid… | 2010 | 24 |
| K091196 | GRS Glenoid Resurfacing System | 2009 | 23 |
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
| K163397 | SMR Hybrid Glenoid System | 2017 | 12 |
| K191814 | Alliance Glenoid | 2019 | 4 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2017 | Class II | Z-2216-2017 | Under Investigation by firm | Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped… |
| Feb 17, 2017 | Class II | Z-1859-2017 | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. |
| Mar 13, 2008 | Not classified | Z-1658-2008 | Device Design | The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid… |
| Dec 6, 12 | Class II | Z-0660-2013 | Nonconforming Material/Component | Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following… |
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 3.5 years on median.
- 9 of the 26 ancestors have a recall of any class.
- Of its descendants, K093430 (Exactech, Inc., 2010) has gone furthest, with 24 descendants of its own.
- 19 other devices also cite its predicate K030710.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
1) Non-inflammatory degenerative joint disease including osteoarthritis 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 arthropathy, where other methods of treatment may not be suitable or may be inadequate
The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060694 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060694: Modular Hybrid Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060694
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