510(k) Report

510(k) · Cleared

Cleared

Taperloc 12/14 Taper Femoral Components

K043537510(k) SpecialCleared Jan 14, 200523-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 14, 2005 as substantially equivalent to K030055 (Biomet, Inc., 2003) and 5 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1997. 160 later devices descend from it.

Decided
Jan 14, 2005
Review
23 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to P960047 (1997). 24 ancestors in all, the oldest K830313 (1983). 160 later devices descend from it, 20 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor1996: 3 other ancestors1994: 6 other ancestors1983: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor2011: 4 descendants cleared2012: 12 descendants cleared2007: 2 descendants cleared2019: 16 descendants cleared2008: 1 descendant cleared2014: 13 descendants cleared2013: 6 descendants cleared2006: 1 descendant cleared2016: 8 descendants cleared2010: 1 descendant cleared2015: 9 descendants cleared2017: 10 descendants cleared2009: 1 descendant cleared2025: 13 descendants cleared2026: 17 descendants cleared2020: 7 descendants cleared2023: 8 descendants cleared2024: 13 descendants cleared2018: 5 descendants cleared2022: 7 descendants cleared2021: 6 descendants clearedP960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 1997×2: 2 generations cleared close together, K021728 (2002), K030047 (2003) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 11 other ancestors 1 generation forward: 20 descendants2 generations forward: 61 descendants3 generations forward: 39 descendants4 generations forward: 25 descendants5 generations forward: 12 descendants6 generations forward: 3 descendants K030047 · Freedom Constrained Liners · Biomet, Inc. · 2003K021728 · Ringloc Constrained Liners II · Biomet, Inc. · 2002P960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 19970+5
  1. Root · 3 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
  2. 2 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
  3. 1 generation backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
  4. This deviceK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. Descendant · cites it directly · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
  7. Descendant · cites it directly · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
  8. Descendant · cites it directly · 20 of its ownK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
  9. Descendant · 2 generations on · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012

Showing 5 of 160 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 12009: 12010: 12011: 42012: 122013: 62014: 132015: 92016: 82017: 102018: 52019: 162020: 72021: 62022: 72023: 82024: 132025: 132026: 17
2006high 17 (2026) · low 1 (2006)2026

Most influential descendants

Showing 5 of 160 · See all
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · cites it directly53descendants
  • K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · cites it directly33descendants
  • K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd. · 2012 · cites it directly20descendants
  • K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · 2 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3P960047Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp.1997—
−2K021728Ringloc Constrained Liners IIBiomet, Inc.2002—
−1K030047Freedom Constrained LinersBiomet, Inc.2003—
0 (this device)K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
+1K121874G7 Acetabular SystemBiomet Manufacturing Corp20123
+2K140669G7 Osseoti Acetublar ShellsBiomet, Inc.2014—
+1K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.2010—
+1K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal…Signature Orthopaedics Pty, Ltd.20122
+2K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198610
199460
199510
199630
199720
199810
199920
200010
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200810
200910
201010
201140
2012120
201360
2014130
201590
201680
2017100
201850
2019160
202070
202160
202270
202380
2024130
2025130
2026170
FIG. 1 — Lineage of K043537, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…
Summary page 1
…2) Prosthesis, hip, semi-constrained, metal/polymer, porous coated, cemented (21 CFR 888.3350) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K030055 - Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis K921301 - Taperloc® Femoral Stem and Universal A…
Biomet, Inc.20033
*K921301Taperloc Femoral Stem and Universal Acetabular Com
Summary page 1
…888.3350) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K030055 - Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis K921301 - Taperloc® Femoral Stem and Universal Acetabular Component K83031 3 - CFE Total Hip Femoral Component - Porous Coated K960984 -…
Biomet, Inc.1994—
*K830313Cfe Total Hip Femoral Component
Summary page 1
…Is Claimed: K030055 - Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis K921301 - Taperloc® Femoral Stem and Universal Acetabular Component K83031 3 - CFE Total Hip Femoral Component - Porous Coated K960984 - SHP Hip System K01 1110 - M2aTM Acetabular System K030047 - Freedom T…
Biomet, Inc.1983—
*K960984SHP Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers
Summary page 1
…d Porous Coated Total Hip Prosthesis K921301 - Taperloc® Femoral Stem and Universal Acetabular Component K83031 3 - CFE Total Hip Femoral Component - Porous Coated K960984 - SHP Hip System K01 1110 - M2aTM Acetabular System K030047 - Freedom TM Constrained Liner Device Description: The Taperloc®)12/…
Biomet, Inc.1996—
*K011110M2A Acetabular System
Summary page 1
…Prosthesis K921301 - Taperloc® Femoral Stem and Universal Acetabular Component K83031 3 - CFE Total Hip Femoral Component - Porous Coated K960984 - SHP Hip System K01 1110 - M2aTM Acetabular System K030047 - Freedom TM Constrained Liner Device Description: The Taperloc®)12/14 Taper Femoral Component…
Biomet, Inc.2001—
*K030047Freedom Constrained Liners
Summary page 1
…c® Femoral Stem and Universal Acetabular Component K83031 3 - CFE Total Hip Femoral Component - Porous Coated K960984 - SHP Hip System K01 1110 - M2aTM Acetabular System K030047 - Freedom TM Constrained Liner Device Description: The Taperloc®)12/14 Taper Femoral Components are straight, collarless, flat,…
Biomet, Inc.2003—

Also cleared against K030055: 5 other devices →

What descends from it? (160)

See all 160

20 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121874G7 Acetabular SystemBiomet Manufacturing Corp201253
K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.201033
K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.201220
K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517
K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.200713
K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211
K112019Bencox ID Stem, Bencox Metal Head, Bencox Bipolar CupCorentec Co., Ltd.201110
K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128
K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157
K110245United Utf StemUnited Orthopedic Corporation20117

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 8 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 2 of the 24 ancestors have a recall of any class.
  • Of its descendants, K121874 (Biomet Manufacturing Corp, 2012) has gone furthest, with 53 descendants of its own.
  • 5 other devices also cite its predicate K030055.

How does its category compare?

All LPH devices

LPH 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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The Taperloc' 12/14 Taper Femoral Components and M a-38TM Modular Heads are indicated for use in cemented or non-cemented total hip replacement 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…

Read the full statement (131 words)

The Taperloc' 12/14 Taper Femoral Components and M a-38TM Modular Heads are indicated for use in cemented or non-cemented total hip replacement 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 joint replacement.

The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

Indications for use as stated in the FDA summary.

Also cleared against K030055

5 other devices cite the same predicate.

  • K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC · 2012
  • K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc. · 2006
  • K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 20051 recall
  • K050251Balance Hip SystemBiomet, Inc. · 2005
  • K042989RX90 Low Profile Acetabular SystemBiomet, Inc. · 2005

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K043537 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043537: Taperloc 12/14 Taper 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/K043537

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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