510(k) Report

510(k) · Cleared

Cleared

Consensus Taperset Hip System

K102399510(k) TraditionalCleared Dec 2, 2010100-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

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

Cleared on Dec 2, 2010 as substantially equivalent to K043537 (Biomet, Inc., 2005) and 19 other predicates after a 100-day review. Its family tree reaches back 6 generations to 1993. 33 later devices descend from it.

Decided
Dec 2, 2010
Review
100 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
20

Its longest line of descent runs back 6 generations to K930712 (1993). 77 ancestors in all, the oldest K810258 (1981). 33 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2003: 5 other ancestors2002: 4 other ancestors1996: 10 other ancestors1995: 7 other ancestors1994: 13 other ancestors1993: 1 other ancestor1992: 2 other ancestors2006: 1 other ancestor2001: 3 other ancestors2000: 4 other ancestors1999: 4 other ancestors1998: 3 other ancestors1983: 1 other ancestor1997: 5 other ancestors1988: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1981: 1 other ancestor2012: 5 descendants cleared2011: 2 descendants cleared2025: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2017: 3 descendants cleared2019: 2 descendants cleared2022: 2 descendants cleared2024: 4 descendants cleared2026: 5 descendants cleared2023: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant clearedK930712 · P.F.C. Total Hip System Porous Coated Modular · Johnson & Johnson Orthopaedics, Inc. · 1993K983014 · Summit Acetabular System · Johnson & Johnson Professionals, Inc. · 1998×2: 2 generations cleared close together, K000306 (2000), K001534 (2000) K031110 · Apex Modular Acetabular Cup · Apex Surgical, LLC · 2003K060635 · Consensus Acetabular Shell System · Hayes Medical, Inc. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 19 other ancestors2 generations back: 13 other ancestors3 generations back: 18 other ancestors4 generations back: 17 other ancestors5 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants K060635 · Consensus Acetabular Shell System · Hayes Medical, Inc. · 2006K031110 · Apex Modular Acetabular Cup · Apex Surgical, LLC · 2003K001534 · Pinnacle Acetabular System · DePuy Orthopaedics, Inc. · 2000K000306 · Pinnacle Acetabular System · DePuy Orthopaedics, Inc. · 2000 · recalledK983014 · Summit Acetabular System · Johnson & Johnson Professionals, Inc. · 1998K930712 · P.F.C. Total Hip System Porous Coated Modular · Johnson & Johnson Orthopaedics, Inc. · 1993−50+5
  1. Root · 6 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
  2. 5 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
  3. 4 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
  4. 3 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
  5. 2 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
  6. 1 generation backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
  7. This deviceK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
  8. Descendant · cites it directly · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
  9. Descendant · 2 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
  10. Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
  11. Descendant · 3 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017
  12. Descendant · 4 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2011: 22012: 52013: 12015: 22016: 12017: 32018: 12019: 22020: 12021: 12022: 22023: 22024: 42025: 12026: 5
2011high 5 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 33 · See all
  • K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · cites it directly20descendants
  • K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 2 generations on19descendants
  • K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
  • K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 3 generations on7descendants
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K930712P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc.1993—
−5K983014Summit Acetabular SystemJohnson & Johnson Professionals, Inc.1998—
−4K000306Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.20001
−3K001534Pinnacle Acetabular SystemDePuy Orthopaedics, Inc.2000—
−2K031110Apex Modular Acetabular CupApex Surgical, LLC2003—
−1K060635Consensus Acetabular Shell SystemHayes Medical, Inc.2006—
0 (this device)K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.2010—
+1K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.2012—
+2K161184iNSitu Total Hip SystemTheken Companies, LLC2016—
+3K163577Ecofit® Hip SystemImplantcast GmbH20171
+3K172501iNSitu Total Hip SystemTheken Companies, LLC2017—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
198510
198620
198810
199220
199310
1994130
199570
1996100
199750
199830
199940
200040
200130
200240
200350
200510
200610
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201250
201310
201520
201610
201730
201810
201920
202010
202110
202220
202320
202440
202510
202650
FIG. 1 — Lineage of K102399, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (20)

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
*K043537Taperloc 12/14 Taper Femoral Components
Summary page 2
…systems in basic design and indications. The monolithic stem with porous CPTi coating is considered to have the same type of technological characteristics as the Biomet K043537 stem with differences in the stem geometry and exterior coating. The subject stem is compatible with previously cleared CoCr head…
Biomet, Inc.2005—
*K921301Taperloc Femoral Stem and Universal Acetabular Com
Summary page 2
…uivalent to legally marketed predicates. Legally Marketed Devices to which Substantial Equivalence is claimed: K043537 (Biomet) Taperloc® 12/14 Taper Femoral components K92 1301 (Biomet) TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM…
Biomet, Inc.1994—
*K030151Consensus Hip System, Unisyn Hip System
Summary page 2
…which Substantial Equivalence is claimed: K043537 (Biomet) Taperloc® 12/14 Taper Femoral components K92 1301 (Biomet) TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K935 193 (U.S. Medical Products) Consensus' Hip System - Porous Coa…
Hayes Medical, Inc.2003—
*K935193Consensus Hip System- Porous Coated Titianium Femoral Stem
Summary page 2
…12/14 Taper Femoral components K92 1301 (Biomet) TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K935 193 (U.S. Medical Products) Consensus' Hip System - Porous Coated Titanium Femnoral Stein K935453 (U.S. Medical Products) CONSENSUS(T…
U.S. Medical Products, Inc.1994—
*K935453Consensus (TM) Hip System-HA Coated Tianium Fem Stem
Summary page 2
…COM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K935 193 (U.S. Medical Products) Consensus' Hip System - Porous Coated Titanium Femnoral Stein K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SY…
U.S. Medical Products, Inc.1994—
*K933499Consensus Hip System- Non-Porous Titanium Femoral Stem
Summary page 2
…Medical Products) Consensus' Hip System - Porous Coated Titanium Femnoral Stein K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTA…
U.S. Medical Products, Inc.1994—
*K922561Consensus (TM) Total Hip System
Summary page 2
…3 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR SYSTEM K070061I (Ha…
U.S. Medical Products, Inc.1993—
*K922560Consensus (TM) Bipolar System
Summary page 2
…NIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR SYSTEM K070061I (Hayes Medical, Inc.) Consensus Hip System 36 min CoCr Femoral f-ea…
U.S. Medical Products, Inc.1992—
*K07006136MM Cocr Femoral Head and 36MM Acetabular Insert
Summary page 2
…HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR SYSTEM K070061I (Hayes Medical, Inc.) Consensus Hip System 36 min CoCr Femoral f-ead K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZ…
Hayes Medical, Inc.2007—
*K953792Consensus Zirconia Head Size -3.5, 0, +5
Summary page 2
…ONSENSUS(TM) TOTAL HIP SYSTEM K(922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR SYSTEM K070061I (Hayes Medical, Inc.) Consensus Hip System 36 min CoCr Femoral f-ead K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5,0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K…
U.S. Medical Products, Inc.1995—
*K955386Consensus Zirconia Femoral Head
Summary page 2
…(TM) BIPOLAR SYSTEM K070061I (Hayes Medical, Inc.) Consensus Hip System 36 min CoCr Femoral f-ead K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5,0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K9601…
U.S. Medical Products, Inc.1996—
*K960339Consensus 22MM Cocrmo Femoral Head
Summary page 2
…ystem 36 min CoCr Femoral f-ead K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5,0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COORMO FEMORAL HEAD K96…
U.S. Medical Products, Inc.1996—
*K960156Consensus 32MM Cocrmo Femoral Head
Summary page 2
…NSENSUS ZIRCONIA HEAD SIZE -3.5,0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COORMO FEMORAL HEAD K9601551 (U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K…
U.S. Medical Products, Inc.1996—
*K960151Consensus 26MM Cocrmo Femoral Head
Our reading of the summary gave K960155, FDA’s number for Unitron Model Sound F/XP (Unitron Industries, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CONSENSUS 26MM COCRMO FEMORAL HEAD”.
U.S. Medical Products, Inc.1996—
*K060635Consensus Acetabular Shell System
Summary page 2
…ONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COORMO FEMORAL HEAD K9601551 (U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular Cuip K030205 (Hayes Medical, Inc.) CONSENSUS UNIPOLAR HEAD, COCR K(0…
Hayes Medical, Inc.2006—
*K030205Consensus Unipolar Head, Cocr
Summary page 2
…S 32MM COORMO FEMORAL HEAD K9601551 (U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular Cuip K030205 (Hayes Medical, Inc.) CONSENSUS UNIPOLAR HEAD, COCR K(02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED PO…
Hayes Medical, Inc.2003—
*K021466Consensus Acetabular Insert, Cross-Linked PolyethyleneHayes Medical, Inc.2002—
*K020153Consensus Acetablar Shell, TI Coated
Summary page 2
…tem, Acetabular Cuip K030205 (Hayes Medical, Inc.) CONSENSUS UNIPOLAR HEAD, COCR K(02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Hayes Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Cons…
Hayes Medical, Inc.2002—
*K953198Corticellous Bone Screw
Summary page 2
…R HEAD, COCR K(02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Hayes Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert, C52 Plus Non-Clinical Performan…
Hayes Medical, Inc.1995—
*K100933Consensus CS2 Plus Acetabular Insert
Cleared while this submission was under review
Summary page 2
…CETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Hayes Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert, C52 Plus Non-Clinical Performance Data: Non-clinical testing and analysis were provid…
Consensus Orthopedics, Inc.2010—

Also cleared against K043537: 19 other devices →

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220
K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114
K122512CS2 Hip SystemConsensus Orthopedics, Inc.20123
K252846TaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20250
K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120
K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120
K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.20110

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 17 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
  • 9 of the 77 ancestors have a recall of any class.
  • Of its descendants, K121935 (Consensus Orthopedics, Inc., 2012) has gone furthest, with 20 descendants of its own.
  • 19 other devices also cite its predicate K043537.

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. 2010, 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?

The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E.…

Read the full statement (112 words)

The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The TaperSet™ hip stem is indicated for cementless use.

Indications for use as stated in the FDA summary.

Also cleared against K043537

19 other devices cite the same predicate.

  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
  • K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
  • K141327Minima S SystemLima Corporate S.P.A. · 2014

More from Consensus Orthopedics, Inc.

17 FDA decisions under this applicant name. See the company

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014

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/K102399 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102399: Consensus Taperset Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102399

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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