510(k) · Cleared
ClearedTrabecular Metal Glenoid- B/F Complete Shoulder Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Trabecular Metal Technology · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 29, 2007 as substantially equivalent to K022377 (Implex Corp., 2002) and 1 other predicate after a 72-day review. Its family tree reaches back 2 generations to 2002. 13 later devices descend from it.
- Decided
- Jun 29, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022377 (2002). 13 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 deviceK071090 Trabecular Metal Glenoid- B/F Complete Shoulder SolutionZimmer Trabecular Metal Technology · 2007
- Descendant · cites it directly · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · 3 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · 4 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- Descendant · 4 generations on · 2 of its ownK222427 PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · cites it directly12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 3 generations on7descendants
- K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 4 generations on3descendants
- K222427PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · 4 generations on2descendants
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) | K071090 | Trabecular Metal Glenoid- B/F Complete Shoulder Solution | Zimmer Trabecular Metal Technology | 2007 | — |
| +1 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | 1 |
| +2 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +3 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +4 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| +4 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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…ith Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449. INDICATIONS FOR USE Prosthetic replacement with this device may be indicated for the treatment of severe pain or s… | 2002 |
| * | K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…Summary page 1…/F humeral components and is available in one thickness option of 5 mm, and the same articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449. INDICATIONS FOR USE Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant d… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163397 | SMR Hybrid Glenoid System | 2017 | 12 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K163397 (Lima Corporate S.P.A., 2017) has gone furthest, with 12 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. 2007, this device’s year, is highlighted.
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 (131 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. In the USA, the device must be cemented under the base
(see surgical technique for details) or fully cemented in place.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071090: Trabecular Metal Glenoid- B/F Complete Shoulder Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071090
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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