510(k) · Cleared
Recalled · Class II · 2021Biomet Modular Femoral Revision 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 Sep 25, 2009 as substantially equivalent to K031693 (Biomet, Inc., 2003) and 4 other predicates after a 186-day review. Its family tree reaches back 5 generations to 1994. 37 later devices descend from it. It has been recalled 18 times.
- Decided
- Sep 25, 2009
- Review
- 186 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 18
- Predicates
- 5
Its longest line of descent runs back 5 generations to K921308 (1994). 24 ancestors in all, the oldest K921274 (1994). 37 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 4 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 3 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 2 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- This deviceK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009
- Descendant · cites it directly · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
- Descendant · cites it directly · 7 of its ownK100469 Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010
- Descendant · 3 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · cites it directly27descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 2 generations on13descendants
- K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · 2 generations on7descendants
- K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010 · cites it directly7descendants
- K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −4 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −3 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −1 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| 0 (this device) | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | — |
| +1 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| +2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
| +1 | K100469 | Arcos Interlocking Distal Stems | Biomet Manufacturing Corp | 2010 | — |
| +3 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K031693 | Mallory/Head Modular Calcar with and Without HASummary page 2…ge 2 === KoqolS~ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K031693 Mallory-Head® Modular Calcar with and without HA-Biomet K042774 Mallory-Head® Modular Calcar St… | 2003 |
| * | K042774 | Mallory-Head Modular Calcar Stems with Interlocking SlotsSummary page 2…KoqolS~ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K031693 Mallory-Head® Modular Calcar with and without HA-Biomet K042774 Mallory-Head® Modular Calcar Stems with Interlocking Slots-Biomet KO013106, K022549 Restoration TM Modula… | 2005 |
| * | K013106 | 2 Piece Modular Hip StemSummary page 2…693 Mallory-Head® Modular Calcar with and without HA-Biomet K042774 Mallory-Head® Modular Calcar Stems with Interlocking Slots-Biomet KO013106, K022549 Restoration TM Modular System-Stryker K994038 Modular Reach® Hip--Biomet Device Description: The… | 2002 |
| * | K022549 | Restoration Modular SystemSummary page 2…Mallory-Head® Modular Calcar with and without HA-Biomet K042774 Mallory-Head® Modular Calcar Stems with Interlocking Slots-Biomet KO013106, K022549 Restoration TM Modular System-Stryker K994038 Modular Reach® Hip--Biomet Device Description: The Biomet®… | 2002 |
| * | K994038 | Modular Reach HipSummary page 2…thout HA-Biomet K042774 Mallory-Head® Modular Calcar Stems with Interlocking Slots-Biomet KO013106, K022549 Restoration TM Modular System-Stryker K994038 Modular Reach® Hip--Biomet Device Description: The Biomet® Modular Revision Femoral System isacomprehensive, pre… | 1999 |
What descends from it? (37)
See all 377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; | 2010 | 27 |
| K100469 | Arcos Interlocking Distal Stems | 2010 | 7 |
| K152903 | REVIVAL (TM) Modular Revision Hip Stem | 2016 | 4 |
| K130063 | Arcos Trochanter Button | 2013 | 3 |
| K242315 | Resolve Modular Revision Hip Stem | 2025 | 0 |
| K152621 | OSS/Arcos IM Total Femur Rod | 2015 | 0 |
| K151603 | Arcos One-piece Femoral Revision System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2021 | Class II | Z-2264-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2274-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2262-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2273-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2268-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2275-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2272-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2267-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2266-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2269-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2259-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2260-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2265-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2270-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2271-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2263-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 2, 2021 | Class II | Z-2261-2021 | Process control | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention |
| Jun 8, 2018 | Class II | Z-2820-2018 | Process control | Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component. |
The 5 latest of 18 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 15 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 11 of the 24 ancestors have a recall of any class.
- Of its descendants, K092331 (Encore Medical L.P., 2010) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K031693.
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. 2009, 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?
1. Noninflammatory degenerative joint disease including osteoarthritis and
avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures
of the proximal femur with head involvement, unmanageable using other
techniques.
5. Revision of previously failed total hip arthroplasty.
The Biomet® Modular Revision Femoral System hip components are single-use implants,
intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090757: Biomet Modular Femoral Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090757
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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