510(k) · Cleared
ClearedX-Series BI-Metric Hip Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 22, 2002 as substantially equivalent to K921224 (Biomet, Inc., 1994) after a 29-day review. Its family tree reaches back 1 generation to 1994. 17 later devices descend from it.
- Decided
- Mar 22, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921224 (1994). 17 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK921224 Bimetric Total Hip SystemBiomet, Inc. · 1994
- This deviceK020580 X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK062775 European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · Recalled
- Descendant · 2 generations on · 5 of its ownK131022 Ovation 10/12 Hip StemOrtho Development Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK141001 Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014
- Descendant · 3 generations on · 3 of its ownK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
- Descendant · 2 generations on · 3 of its ownK133386 Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007 · cites it directly13descendants
- K131022Ovation 10/12 Hip StemOrtho Development Corp. · 2013 · 2 generations on5descendants
- K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014 · 2 generations on4descendants
- K173880Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018 · 3 generations on3descendants
- K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921224 | Bimetric Total Hip System | Biomet, Inc. | 1994 | — |
| 0 (this device) | K020580 | X-Series BI-Metric Hip Femoral Components | Biomet, Inc. | 2002 | — |
| +1 | K062775 | European Style Taper,Press-Fit Hip Stem | Ortho Development Corp. | 2007 | 4 |
| +2 | K131022 | Ovation 10/12 Hip Stem | Ortho Development Corp. | 2013 | — |
| +2 | K141001 | Alpine Hip Stem; Alpine HA Hip Stem | Ortho Development | 2014 | — |
| +3 | K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018 | — |
| +2 | K133386 | Ovation Tribute Hip Stem; Ovation Narrow Hip Stem | Ortho Development Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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 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 24.3 · 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? (1)
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 |
|---|---|---|---|
| * | K921224 | Bimetric Total Hip SystemSummary page 1…i-constrained, metal/polymer, porous coated uncemented (888.3558 Legally Marketed Device to which Substantial Equivalence is Claimed: Bi- Metric® Hip Femoral Component (K921224) Device Description: The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® femoral components in… | 1994 |
What descends from it? (17)
See all 174 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?
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?
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020580: X-Series BI-Metric Hip Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020580
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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