510(k) · Cleared
ClearedShort and Long Soft Tissue Attachment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Sep 24, 2002 as substantially equivalent to K913282 (Turnkey Intergration USA, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994. 16 later devices descend from it.
- Decided
- Sep 24, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925613 (1994). 3 ancestors in all, the oldest K913282 (1991). 16 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK925613 Proximal Humeral Replacement SystemBiomet, Inc. · 1994
- 1 generation backK020045 3-Piece Proximal Humeral Replacement SystemBiomet Orthopedics, Inc. · 2002
- This deviceK022079 Short and Long Soft Tissue AttachmentBiomet, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- Descendant · 2 generations on · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · cites it directly15descendants
- K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 2 generations on9descendants
- K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · 2 generations on8descendants
- K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · cites it directly7descendants
- K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925613 | Proximal Humeral Replacement System | Biomet, Inc. | 1994 | — |
| −1 | K020045 | 3-Piece Proximal Humeral Replacement System | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K022079 | Short and Long Soft Tissue Attachment | Biomet, Inc. | 2002 | — |
| +1 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| +2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| +2 | K043505 | Discovery-Mosaic Total Humerus System | Biomet, Inc. | 2005 | — |
| +1 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| +2 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K913282 | Lima RPS ShoulderSummary page 1…cemented (21 CFR 888.3650) Legally Marketed Devices to Which Substantial Equivalence is Claimed: 1. LIMA RPS Shoulder (K913282) 2. Biomet Modular Proximal Humeral Replacement System (K020045), now known as t… | 1991 |
| * | K020045 | 3-Piece Proximal Humeral Replacement SystemSummary page 1…is Claimed: 1. LIMA RPS Shoulder (K913282) 2. Biomet Modular Proximal Humeral Replacement System (K020045), now known as the MosaicTM Humeral System Device Description: This particular design utilize… | 2002 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033280 (Biomet, Inc., 2003) has gone furthest, with 15 descendants of its own.
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 indications for the use of the Short and Long Soft Tissue Attachment Sleeves include:
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. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
The sleeves can be used for oncology applications.
The sleeves are designed for use with the Biomet MosaicTM Humeral System (K020045), to provide the option for soft tissue stabilization and attachment.
The Biomet MosaicTM Humeral System (K020045) is for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022079: Short and Long Soft Tissue Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022079
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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