510(k) · Cleared
ClearedComprehensive Humeral Fracture Positioning Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Feb 2, 2004 as substantially equivalent to K032507 (Biomet, Inc., 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Feb 2, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872454 (1987). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK872454 Biomet Modular Shoulder ProsthesisBiomet, Inc. · 1987
- 2 generations backK961571 Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996
- 1 generation backK023063 Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · Recalled
- This deviceK033506 Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK212435 Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872454 | Biomet Modular Shoulder Prosthesis | Biomet, Inc. | 1987 | — |
| −2 | K961571 | Cocr BI-Angular Humeral Component | Biomet, Inc. | 1996 | — |
| −1 | K023063 | Comprehensive Humeral Fracture System | Biomet Orthopedics, Inc. | 2002 | 2 |
| 0 (this device) | K033506 | Comprehensive Humeral Fracture Positioning Sleeve | Biomet, Inc. | 2004 | — |
| +1 | K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021 | — |
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 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K032507 | Interlok Bio-Modular Humeral StemsSummary page 1…mer semi-constrained cemented prosthesis (888.3660) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Bio-Modular Centering Sleeve (K032507):. Biomet, Inc. * Comprehensive Humeral Fracture Stem (K023063):. Biomet, Inc. Device Description: The Comprehens… | 2003 |
| * | K023063 | Comprehensive Humeral Fracture SystemSummary page 1…To Which Substantial Equivalence Is Claimed: * Bio-Modular Centering Sleeve (K032507):. Biomet, Inc. * Comprehensive Humeral Fracture Stem (K023063):. Biomet, Inc. Device Description: The Comprehensive Hurmeral Fracture Positioning Sleeve is composed of Polymethylmethacrylate… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | 2021 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K212435 (Biomet, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032507.
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?
The Comprehensive Humeral Fracture Positioning Sleeve is 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 arthopathy, where other methods of treatment may not be suitable or may be inadequate.
For Cemented Use Only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033506 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033506: Comprehensive Humeral Fracture Positioning Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033506
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