510(k) · Cleared
ClearedThe Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-XX-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 23, 2004 as substantially equivalent to K022377 (Implex Corp., 2002) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 2002. 58 later devices descend from it.
- Decided
- Nov 23, 2004
- Review
- 18 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022377 (2002). 58 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK022377 The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder…Implex Corp. · 2002 · Recalled
- 1 generation backK031449 Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the…Implex Corp. · 2003 · Recalled
- This deviceK043061 The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…Zimmer Trabecular · 2004
- Descendant · cites it directly · 57 of its ownK060694 Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · Recalled
- Descendant · 2 generations on · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 23 of its ownK091196 GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009
- Descendant · 3 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K060694Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · cites it directly57descendants
- K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · 2 generations on24descendants
- K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009 · 2 generations on23descendants
- K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 3 generations on22descendants
- K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022377 | The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution… | Implex Corp. | 2002 | 8 |
| −1 | K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete… | Implex Corp. | 2003 | 8 |
| 0 (this device) | K043061 | The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution… | Zimmer Trabecular | 2004 | — |
| +1 | K060694 | Modular Hybrid Glenoid | Biomet Manufacturing Corp | 2006 | 4 |
| +2 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| +2 | K091196 | GRS Glenoid Resurfacing System | Arthrosurface, Inc. | 2009 | — |
| +3 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| +4 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K022377 | The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306Summary page 1…d is available in one thickness option of 5 mm, and the same outer geometry and dimensions as the B/F glenoids cleared in K022377 and K031449. November 3, 2004 Zimmer Trabecular Metal Technology, Inc.… | 2002 |
| * | K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…Summary page 1…available in one thickness option of 5 mm, and the same outer geometry and dimensions as the B/F glenoids cleared in K022377 and K031449. November 3, 2004 Zimmer Trabecular Metal Technology, Inc. TM Glenoid,B… | 2003 |
What descends from it? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060694 | Modular Hybrid Glenoid | 2006 | 57 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K060694 (Biomet Manufacturing Corp, 2006) has gone furthest, with 57 descendants of its own.
- 4 other devices also cite its predicate K022377.
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?
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The…
Read the full statement (125 words)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043061: The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-XX-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043061
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