510(k) · Cleared
ClearedCompress Anti-Rotation Spindles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Jun 18, 2010 as substantially equivalent to K062998 (Biomet Manufacturing Corp, 2007) and 1 other predicate after a 21-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jun 18, 2010
- Review
- 21 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945028 (1996). 8 ancestors in all, the oldest K952970 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 4 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
- 3 generations backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- 2 generations backK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005 · Recalled
- 1 generation backK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
- This deviceK101475 Compress Anti-Rotation SpindlesBiomet Manufacturing Corp · 2010
- Descendant · cites it directly · 0 of its ownK183553 Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −4 | K031804 | Compress Distal Femoral Replacement | Biomet, Inc. | 2003 | — |
| −3 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| −2 | K043547 | Compress Segmental Femoral Replacement System | Biomet, Inc. | 2005 | 6 |
| −1 | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) | Biomet Manufacturing Corp | 2007 | 21 |
| 0 (this device) | K101475 | Compress Anti-Rotation Spindles | Biomet Manufacturing Corp | 2010 | — |
| +1 | K183553 | Compress and Mini Compress Anti-Rotation Spindles | Biomet, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Summary page 2…es Page 2 of 2 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Compress®~Segmental Femoral Replacement System (Short Spindle and Anchor Plugs) - K062998 Compress®D Segmental Femoral Replacement System - K043547 Device Description: The Comnpress® Segmental Anti-Rotation Spindles ar… | 2007 |
| * | K043547 | Compress Segmental Femoral Replacement SystemSummary page 2…ntial Equivalence Is Claimed: Compress®~Segmental Femoral Replacement System (Short Spindle and Anchor Plugs) - K062998 Compress®D Segmental Femoral Replacement System - K043547 Device Description: The Comnpress® Segmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a s… | 2005 |
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 |
|---|---|---|---|
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | 2019 | 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 14 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K183553 (Biomet, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062998.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Compress® Segmental Femoral Replacement System is indicated for:
1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
The Compress® Segmental Femoral Replacement System components are intended for uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101475: Compress Anti-Rotation Spindles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101475
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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