510(k) · Cleared
Recalled · 2009Compress Segmental Femoral Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Aug 5, 2005 as substantially equivalent to K031804 (Biomet, Inc., 2003) and 4 other predicates after a 225-day review. Its family tree reaches back 3 generations to 1996. 11 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 5, 2005
- Review
- 225 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 6
- Predicates
- 5
Its longest line of descent runs back 3 generations to K945028 (1996). 6 ancestors in all, the oldest K952970 (1996). 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 2 generations backK031804 Compress Distal Femoral ReplacementBiomet, Inc. · 2003
- 1 generation backK041352 Compress Distal Femoral Replacement SystemBiomet, Inc. · 2004
- This deviceK043547 Compress Segmental Femoral Replacement SystemBiomet, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK062998 Compress Segmental Femoral Replacement System (Short Spindle and…Biomet Manufacturing Corp · 2007 · Recalled
- Descendant · 2 generations on · 5 of its ownK112905 Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- Descendant · cites it directly · 2 of its ownK080330 Segmental Distal Femoral Components and Proximal Femoral Bodies with…Biomet, Inc. · 2008
- Descendant · 4 generations on · 1 of its ownK223631 Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp · 2007 · cites it directly10descendants
- K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC · 2012 · 2 generations on5descendants
- K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 3 generations on2descendants
- K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc. · 2008 · cites it directly2descendants
- K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −2 | K031804 | Compress Distal Femoral Replacement | Biomet, Inc. | 2003 | — |
| −1 | K041352 | Compress Distal Femoral Replacement System | Biomet, Inc. | 2004 | — |
| 0 (this device) | K043547 | Compress Segmental Femoral Replacement System | Biomet, Inc. | 2005 | — |
| +1 | K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) | Biomet Manufacturing Corp | 2007 | 21 |
| +2 | K112905 | Compress (R) Segmental Humeral Replacement System | Biomet Orthopedics, LLC | 2012 | 2 |
| +3 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| +1 | K080330 | Segmental Distal Femoral Components and Proximal Femoral Bodies with a… | Biomet, Inc. | 2008 | — |
| +4 | K223631 | Comprehensive Segmental Revision System (SRS) | Biomet Orthopedics | 2023 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 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? (5)
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 |
|---|---|---|---|
| * | K031804 | Compress Distal Femoral ReplacementSummary page 2…yo cc'i Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ConmfreSs" Distal Femoral Replacement System -Riomet Inc. (K031804, K041352) Orthopedic Salvage System (OSS) -Biomet Inc. (K002757) Modular Replacement System (MRS) - Howmedica (K9… | 2003 |
| * | K041352 | Compress Distal Femoral Replacement SystemSummary page 2…cc'i Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ConmfreSs" Distal Femoral Replacement System -Riomet Inc. (K031804, K041352) Orthopedic Salvage System (OSS) -Biomet Inc. (K002757) Modular Replacement System (MRS) - Howmedica (K952970, K9… | 2004 |
| * | K002757 | Oncology Salvage SystemSummary page 2…ntial Equivalence Is Claimed: ConmfreSs" Distal Femoral Replacement System -Riomet Inc. (K031804, K041352) Orthopedic Salvage System (OSS) -Biomet Inc. (K002757) Modular Replacement System (MRS) - Howmedica (K952970, K97240l) Device Description: The Compre~ss® Segmental F… | 2000 |
| * | K952970 | Howmedica Femoral & Proximal Tibial Modular Replacement SytesmSummary page 2…l Replacement System -Riomet Inc. (K031804, K041352) Orthopedic Salvage System (OSS) -Biomet Inc. (K002757) Modular Replacement System (MRS) - Howmedica (K952970, K97240l) Device Description: The Compre~ss® Segmental Femoral Replacement System consists of three main components, th… | 1996 |
| * | K972401 | Howmedica Modular Replacement System - Distal Femoral/Proximal Tibial Segments | 1998 |
What descends from it? (11)
See all 113 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2009 | Not classified | Z-1528-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1530-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1527-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1529-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1531-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
| May 19, 2009 | Not classified | Z-1526-2009 | Process control | The retaining ring may fall out of the instrument during surgery. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K062998 (Biomet Manufacturing Corp, 2007) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K031804.
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.
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?
Indications:
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 only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043547: Compress Segmental Femoral Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043547
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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