510(k) · Cleared
ClearedTaperloc Femoral Stem and Universal Acetabular Com
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 Feb 16, 1994 after a 700-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 384 devices in its family, counting itself, has a Class I recall. 383 later devices descend from it.
- Decided
- Feb 16, 1994
- Review
- 700 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
383 later devices descend from it, 14 citing it directly. 1 of the 384 devices in this family, counting this one, has a Class I recall.
- This deviceK921301 Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc. · 1994
- Descendant · cites it directly · 234 of its ownK020963 Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized…Biomet Orthopedics, Inc. · 2002
- Descendant · 2 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · cites it directly · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 3 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 383 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…3 generations on · 2007
Most influential descendants
Showing 5 of 383 · See all- K020963Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral StemBiomet Orthopedics, Inc. · 2002 · cites it directly234descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 2 generations on166descendants
- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · cites it directly160descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 3 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921301 | Taperloc Femoral Stem and Universal Acetabular Com | Biomet, Inc. | 1994 | — |
| +1 | K020963 | Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem | Biomet Orthopedics, Inc. | 2002 | — |
| +2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +1 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +3 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 1 |
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 15 | 0 |
| 2012 | 29 | 0 |
| 2013 | 26 | 0 |
| 2014 | 19 | 0 |
| 2015 | 17 | 0 |
| 2016 | 17 | 0 |
| 2017 | 23 | 0 |
| 2018 | 21 | 0 |
| 2019 | 31 | 0 |
| 2020 | 25 | 0 |
| 2021 | 13 | 0 |
| 2022 | 19 | 0 |
| 2023 | 19 | 0 |
| 2024 | 23 | 0 |
| 2025 | 22 | 0 |
| 2026 | 24 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (383)
See all 38314 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020963 | Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem | 2002 | 234 |
| K043537 | Taperloc 12/14 Taper Femoral Components | 2005 | 160 |
| K050441 | Taper 2 Porous Femoral Stem | 2005 | 85 |
| K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | 2003 | 84 |
| K994366 | TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem | 2000 | 76 |
| K102399 | Consensus Taperset Hip System | 2010 | 33 |
| K062775 | European Style Taper,Press-Fit Hip Stem | 2007 | 13 |
| K121034 | Ioi Total Hip | 2012 | 11 |
| K121777 | U2 Acetabular Cup, Plasma Spray | 2012 | 9 |
| K110245 | United Utf Stem | 2011 | 7 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020963 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 234 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 | — |
https://510kreport.com/device/K921301 · printed Nov 5, 2026
Cite this page
510(k) Report. “K921301: Taperloc Femoral Stem and Universal Acetabular Com.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921301
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026