510(k) · Cleared
ClearedTaperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Apr 16, 2002 as substantially equivalent to K921301 (Biomet, Inc., 1994) after a 22-day review. Its family tree reaches back 1 generation to 1994. 1 of the 236 devices in its family, counting itself, has a Class I recall. 234 later devices descend from it.
- Decided
- Apr 16, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921301 (1994). 234 later devices descend from it, 2 citing it directly. 1 of the 236 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK921301 Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc. · 1994
- This deviceK020963 Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized…Biomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 2 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- Descendant · cites it directly · 84 of its ownK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
Showing 5 of 234 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 234 · See all- K043079Bicontact Hip System with U-CapAesculap · 2004 · cites it directly166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 2 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
- K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
- K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · cites it directly84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921301 | Taperloc Femoral Stem and Universal Acetabular Com | Biomet, Inc. | 1994 | — |
| 0 (this device) | K020963 | Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +2 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +3 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| +2 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| +1 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 1 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 12 | 0 |
| 2013 | 17 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 20 | 0 |
| 2020 | 18 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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.
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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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 |
|---|---|---|---|
| * | K921301 | Taperloc Femoral Stem and Universal Acetabular ComSummary page 1…/polymer, non- porous, calcium-phosphate Device Classification: Class II Legally Marketed Device to which Substantially Equivalence is Claimed: Taperloc® Femoral Stem (K921301) Device Description: The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the p… | 1994 |
What descends from it? (234)
See all 2342 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 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 using other techniques; and 5) Revision procedures where other treatments or devices have failed.
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/K020963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020963: Taperloc Porous Femoral Stem & HA Taperloc Porous Lateralized Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020963
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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