510(k) · Cleared
Recalled · Class II · 2017Comprehensive Humeral Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Dec 13, 2002 as substantially equivalent to K984541 (DePuy Orthopaedics, Inc., 1999) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1987. 146 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 13, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KWT
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K872454 (1987). 11 ancestors in all. 146 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK872454 Biomet Modular Shoulder ProsthesisBiomet, Inc. · 1987
- 1 generation backK961571 Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996
- This deviceK023063 Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
- Descendant · 2 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 97 of its ownK121493 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · cites it directly138descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 2 generations on110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on98descendants
- K121493Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872454 | Biomet Modular Shoulder Prosthesis | Biomet, Inc. | 1987 | — |
| −1 | K961571 | Cocr BI-Angular Humeral Component | Biomet, Inc. | 1996 | — |
| 0 (this device) | K023063 | Comprehensive Humeral Fracture System | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K060692 | Comprehensive Primary Shoulder Stems | Biomet Manufacturing Corp | 2006 | 6 |
| +2 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K121493 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 1…osthesis (888.3690) Device Classification: Class I1 Legally Marketed Devices to which Substantial Equivalence is Claimed: DePuy Orthopaedics’ Global@ Shoulder- 5 1O(k) K984541, Biomet, Inc.’s Bi-Angular Co-Cr Humeral Components- 5 1O(k) K961571, Kirschner Shoulders With Titanium Plasma Spray- 5 1O(k) K96… | 1999 |
| * | K961571 | Cocr BI-Angular Humeral ComponentSummary page 1…d Devices to which Substantial Equivalence is Claimed: DePuy Orthopaedics’ Global@ Shoulder- 5 1O(k) K984541, Biomet, Inc.’s Bi-Angular Co-Cr Humeral Components- 5 1O(k) K961571, Kirschner Shoulders With Titanium Plasma Spray- 5 1O(k) K96 1260, and Bio-Modular Shoulder System- 5 1O(k) K992 1 19. Device De… | 1996 |
| * | K961260 | Kirschner Sholders with Titanium Plasma SpraySummary page 1…opaedics’ Global@ Shoulder- 5 1O(k) K984541, Biomet, Inc.’s Bi-Angular Co-Cr Humeral Components- 5 1O(k) K961571, Kirschner Shoulders With Titanium Plasma Spray- 5 1O(k) K96 1260, and Bio-Modular Shoulder System- 5 1O(k) K992 1 19. Device Description: The Comprehensive Humeral Fracture Stems consists of va… | 1997 |
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…, Inc.’s Bi-Angular Co-Cr Humeral Components- 5 1O(k) K961571, Kirschner Shoulders With Titanium Plasma Spray- 5 1O(k) K96 1260, and Bio-Modular Shoulder System- 5 1O(k) K992 1 19. Device Description: The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an InterlokB… | 1999 |
What descends from it? (146)
See all 1465 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060692 | Comprehensive Primary Shoulder Stems | 2006 | 138 |
| K040610 | Versa-Dial Humeral Head | 2004 | 17 |
| K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem | 2010 | 2 |
| K033506 | Comprehensive Humeral Fracture Positioning Sleeve | 2004 | 1 |
| K140652 | Porous Coated Comprehensive Fracture Stems | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2017 | Class II | Z-0298-2018 | 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. |
| Aug 3, 2011 | Not classified | Z-3289-2011 | Nonconforming Material/Component | Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K060692 (Biomet Manufacturing Corp, 2006) has gone furthest, with 138 descendants of its own.
- 9 other devices also cite its predicate K984541.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Comprehensive Humeral Fracture Stems are 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; and 6) Difficult clinical management problems, including cuff arthropathy, where other…
Read the full statement (97 words)
The Comprehensive Humeral Fracture Stems are 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; and 6) Difficult clinical management problems, including cuff arthropathy, where
other methods of treatment may not be suitable or may be inadequate.
The InterlokB finish Comprehensive Humeral Fracture Stems are intended for cemented use and
the MacroBondThfcoated Comprehensive Humeral Fracture Stems are intended for press-fit or
cemented application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023063: Comprehensive Humeral Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023063
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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