510(k) Report

510(k) · Cleared

Cleared

Taperloc® Complete Hip Stem

K251270510(k) TraditionalCleared May 19, 2026390-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 May 19, 2026 as substantially equivalent to K120030 (Biomet Manufacturing Corp, 2012) and 3 other predicates after a 390-day review. Its family tree reaches back 8 generations to 1985.

Decided
May 19, 2026
Review
390 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K850055 (1985). 53 ancestors in all, the oldest K845025 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2020: 1 other ancestor2011: 1 other ancestor2010: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2004: 2 other ancestors2002: 2 other ancestors1997: 3 other ancestors1996: 4 other ancestors1994: 6 other ancestors2001: 2 other ancestors2000: 5 other ancestors1999: 2 other ancestors1998: 2 other ancestors1990: 1 other ancestor1987: 2 other ancestors1995: 2 other ancestors1988: 2 other ancestors1985: 1 other ancestor1991: 1 other ancestorK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK110400 · Taperloc Complete Microplasty Stem · Biomet Manufacturing Corp · 2011K120030 · Taperloc Complete Size 4MM and XR 123 · Biomet Manufacturing Corp · 20121990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 8 other ancestors5 generations back: 18 other ancestors6 generations back: 10 other ancestors7 generations back: 2 other ancestors K120030 · Taperloc Complete Size 4MM and XR 123 · Biomet Manufacturing Corp · 2012K110400 · Taperloc Complete Microplasty Stem · Biomet Manufacturing Corp · 2011K071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 6 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 5 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 4 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 3 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. 2 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  8. 1 generation backK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
  9. This deviceK251270 Taperloc® Complete Hip StemBiomet, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K850055Profile Femoral HipDepuy, Inc.1985—
−7K961378Delta Hip ProsthesisZimmer, Inc.19964
−6K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−5K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−4K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−3K071723Zimmer Porolock Mis StemZimmer GmbH20082
−2K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
−1K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp2012—
0 (this device)K251270Taperloc® Complete Hip StemBiomet, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198720
198820
199010
199110
199460
199520
199640
199730
199820
199920
200050
200120
200220
200320
200420
200510
200610
200710
201010
201110
202010
FIG. 1 — Lineage of K251270, 1985–2026Source: 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 24.2 · 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? (4)

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
*K120030Taperloc Complete Size 4MM and XR 123
Summary page 5
…Manufacturer 510(k) Number Primary Taperloc® Complete Size Biomet Manufacturing Corp K120030 Predicate 4mm and XR123 Stems Taperloc® Complete Hip Biom…
Biomet Manufacturing Corp2012—
*K200196Taperloc® Complete Hip Stems
Summary page 5
…Corp K120030 Predicate 4mm and XR123 Stems Taperloc® Complete Hip Biomet Orthopedic K200196 Stems Additional Taperloc® Complete Biomet Manufacturing C…
Biomet Orthopedics2020—
*K110400Taperloc Complete Microplasty Stem
Summary page 5
…met Orthopedic K200196 Stems Additional Taperloc® Complete Biomet Manufacturing Corp K110400 Predicates Microplasty Hip Stem Taperloc® Complete Size Bi…
Biomet Manufacturing Corp2011—
*K103755Taperloc Complete, Size 5 and 6
Summary page 5
…rp K110400 Predicates Microplasty Hip Stem Taperloc® Complete Size Biomet Manufacturing Corp K103755 5mm and 6mm 510(k…
Biomet Manufacturing Corp2011—

Also cleared against K120030: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 41 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
  • 12 of the 53 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K120030.

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. 2026, this device’s year, is highlighted.

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?

Biomet Taperloc Complete stems are porous coated femoral stems intended for uncemented biological fixation. They are offered in various sizes and offsets, as well as standard full-length and shortened Microplasty® stem lengths. BoneMaster™ HA coated stems, the only available HA coating for Taperloc Complete stems, are for sale outside the United States only. The Taperloc Complete hip stems can be used for either total or hemi hip arthroplasty.…

Read the full statement (127 words)

Biomet Taperloc Complete stems are porous coated femoral stems intended for uncemented biological fixation. They are offered in various sizes and offsets, as well as standard full-length and shortened Microplasty® stem lengths. BoneMaster™ HA coated stems, the only available HA coating for Taperloc Complete stems, are for sale outside the United States only. The Taperloc Complete hip stems can be used for either total or hemi hip arthroplasty.

INDICATIONS

1. Noninflammatory 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 procedures where other treatment or devices have failed.

Porous coated components are intended for uncemented biological fixation.

Indications for use as stated in the FDA summary.

Also cleared against K120030

3 other devices cite the same predicate.

  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, 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
  • K213287StageOne Knee 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/K251270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251270: Taperloc® Complete Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251270

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 Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026