510(k) · Cleared
ClearedPegged Acetabular Component
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 Apr 30, 1997 after a 79-day review. The FDA summary names its predicate without a number. 509 later devices descend from it.
- Decided
- Apr 30, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
509 later devices descend from it, 3 citing it directly.
- This deviceK970501 Pegged Acetabular ComponentBiomet, Inc. · 1997
- Descendant · cites it directly · 505 of its ownK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- Descendant · cites it directly · 480 of its ownK023357 Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
Showing 5 of 509 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 509 · See all- K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · cites it directly505descendants
- K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc. · 2002 · cites it directly480descendants
- K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 2 generations on355descendants
- K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 3 generations on344descendants
- K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 4 generations on343descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970501 | Pegged Acetabular Component | Biomet, Inc. | 1997 | — |
| +1 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| +1 | K023357 | Arcpm 1050 Resin-Hips | Biomet Orthopedics, Inc. | 2002 | 1 |
| +2 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| +3 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| +4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 14 | 0 |
| 2012 | 26 | 0 |
| 2013 | 34 | 0 |
| 2014 | 29 | 0 |
| 2015 | 24 | 0 |
| 2016 | 26 | 0 |
| 2017 | 22 | 0 |
| 2018 | 26 | 0 |
| 2019 | 37 | 0 |
| 2020 | 34 | 0 |
| 2021 | 32 | 0 |
| 2022 | 34 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 39 | 0 |
| 2026 | 34 | 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? (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 |
|---|---|---|---|
| * | — | Universal® Acetabular Component Named without a submission number | |
| * | — | Mallory-Head® Acetabular Component Named without a submission number | |
| * | — | Reflection™ Porous-Coated Acetabular Component Named without a submission number | |
| * | — | PCA® Acetabular Component Named without a submission number | |
| * | — | Duraloc™ 300 Acetabular Cup System Named without a submission number |
What descends from it? (509)
See all 5093 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?
- Of its descendants, K032396 (Biomet, Inc., 2003) has gone furthest, with 505 descendants of its own.
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 Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.
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/K970501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970501: Pegged Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970501
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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