510(k) · Cleared
ClearedXR-Series BI-Metric Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 17, 2006 as substantially equivalent to K020580 (Biomet, Inc., 2002) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Feb 17, 2006
- Review
- 199 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854046 (1985). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
- 2 generations backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
- 1 generation backK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
- This deviceK052089 XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073637 Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp · 2008
Most influential descendants
Showing 1 of 1 · See all- K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854046 | Conical Collar Hip Prosthesis | Kirschner Medical Corp. | 1985 | — |
| −2 | K960303 | Fenning Femoral Component | Biomet, Inc. | 1996 | — |
| −1 | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric… | Biomet, Inc. | 2003 | 3 |
| 0 (this device) | K052089 | XR-Series BI-Metric Femoral Components | Biomet Manufacturing, Inc. | 2006 | — |
| +1 | K073637 | Parallel-Sided Extensively Coated Femoral Stems | Biomet Manufacturing Corp | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K020580 | X-Series BI-Metric Hip Femoral ComponentsSummary page 1…uncemnented prosthesis. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Bi-Metrice X- Series Hip Femoral Components, originally cleared by 510(k) K020580, 03/22/02 and cleared for expanded indications by 510O(k) K(030055, 8/11/03. Device Description: The XR-Series Ri-Metric®)femora… | 2002 |
| * | K030055 | Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Summary page 1…ial Equivalence Is Claimed: Bi-Metrice X- Series Hip Femoral Components, originally cleared by 510(k) K020580, 03/22/02 and cleared for expanded indications by 510O(k) K(030055, 8/11/03. Device Description: The XR-Series Ri-Metric®)femoral components are identical to the predicate Ri-Metric® X-Series fem… | 2003 |
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 |
|---|---|---|---|
| K073637 | Parallel-Sided Extensively Coated Femoral Stems | 2008 | 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 21 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K073637 (Biomet Manufacturing Corp, 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K020580.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The XR-Series Bi-Metric® Femoral Components are intended for
cemented or uncemented use in cases of:
1) Non-inflammatory 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 by other techniques.
5) Revision of previously failed total joint replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052089: XR-Series BI-Metric Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052089
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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