510(k) Report

510(k) · Cleared

Cleared

Consensus Knee System

K102927510(k) TraditionalCleared Jan 26, 2011114-day reviewClass II21 CFR 888.3565

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

Consensus Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Jan 26, 2011 as substantially equivalent to K001456 (Hayes Medical, Inc., 2000) and 6 other predicates after a 114-day review. Its family tree reaches back 5 generations to 1995.

Decided
Jan 26, 2011
Review
114 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K951987 (1995). 36 ancestors in all, the oldest K833921 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2004: 1 other ancestor2003: 3 other ancestors2000: 3 other ancestors1998: 2 other ancestors2006: 1 other ancestor2001: 2 other ancestors1997: 2 other ancestors1996: 2 other ancestors1995: 3 other ancestors1994: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1984: 1 other ancestor2005: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestorK951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled×2: 2 generations cleared close together, K030612 (2003), K032295 (2003) K041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K051229 · Profix Flex Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 20051980198519901995200020052010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 17 other ancestors3 generations back: 7 other ancestors4 generations back: 1 other ancestor K051229 · Profix Flex Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K041825 · Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert · Smith & Nephew, Inc. · 2005K032295 · Genesis II Posterior Stabilized High Flexion Articular Insert · Smith & Nephew, Inc. · 2003 · recalledK030612 · Genesis II Total Knee System · Smith & Nephew, Inc. · 2003K951987 · Genesis II Total Knee System · Smith & Nephew Richards, Inc. · 1995 · recalled−50
  1. Root · 5 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
  2. 4 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
  3. 3 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
  4. 2 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
  5. 1 generation backK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005
  6. This deviceK102927 Consensus Knee SystemConsensus Orthopedics, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc.19956
−4K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003—
−3K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.20036
−2K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
−1K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
0 (this device)K102927Consensus Knee SystemConsensus Orthopedics, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
198910
199110
199210
199410
199530
199620
199720
199820
199910
200030
200120
200210
200330
200410
200510
200610
200720
200810
FIG. 1 — Lineage of K102927, 1995–2011Source: 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 MBH? 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 MBH device

  1. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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? (7)

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
*K001456Consensus Knee System
Summary page 2
…or without cement. Substantial Equivalence: The CKS porous coated components that are the subject of this submission were previously cleared by FDA for cemented use in K001456 (femoral components) and K983004 (tibial components). This submission is to expand the indications to allow their uncemented use.…
Hayes Medical, Inc.2000—
*K983004Consensus Femoral Component, Porous, Cocr/TI
Summary page 2
…quivalence: The CKS porous coated components that are the subject of this submission were previously cleared by FDA for cemented use in K001456 (femoral components) and K983004 (tibial components). This submission is to expand the indications to allow their uncemented use. The previous 51O(k)'s for these…
Hayes Medical, Inc.1998—
*K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
*K030623Smith & Nephew Profix Total Knee System
Summary page 2
…8. The CKS implants are also substantially equivalent to the following knee systems that are cleared for cementless use: Smith & Nephew's "ProFix Total Knee" (KOS51229 & K030623), Biomet's "AGC Total Knee" (K033489), and Zimmer's "Natural Knee" (K073286 & K0702 14). Non-Clinical Performance Data: Modifie…
Smith & Nephew, Inc.2003—
*K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…
Summary page 2
…ially equivalent to the following knee systems that are cleared for cementless use: Smith & Nephew's "ProFix Total Knee" (KOS51229 & K030623), Biomet's "AGC Total Knee" (K033489), and Zimmer's "Natural Knee" (K073286 & K0702 14). Non-Clinical Performance Data: Modified Surface Testing Specifications and…
Biomet, Inc.2004—
*K073286Gender Solutions Natural-Knee Flex System
Summary page 2
…systems that are cleared for cementless use: Smith & Nephew's "ProFix Total Knee" (KOS51229 & K030623), Biomet's "AGC Total Knee" (K033489), and Zimmer's "Natural Knee" (K073286 & K0702 14). Non-Clinical Performance Data: Modified Surface Testing Specifications and Results: The porous CoCr bead with Ti c…
Zimmer, Inc.20085
*K070214Gender Solutions Natural-Knee Flex System
Summary page 2
…at are cleared for cementless use: Smith & Nephew's "ProFix Total Knee" (KOS51229 & K030623), Biomet's "AGC Total Knee" (K033489), and Zimmer's "Natural Knee" (K073286 & K0702 14). Non-Clinical Performance Data: Modified Surface Testing Specifications and Results: The porous CoCr bead with Ti coating surf…
Zimmer, Inc.200763

Also cleared against K001456: 6 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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 16 of the 36 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K001456.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.

B. Failed osteotomy or unicompatmental replacements.

C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

Indications for use as stated in the FDA summary.

Also cleared against K001456

6 other devices cite the same predicate.

  • K241180Consensus Knee System with TiNbNShalby Advanced Technologies · 2025
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
  • K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert /…Tgm Medical, Inc. · 2011
  • K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 20091 recall

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 MBH

The MBH category page

  • K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K102927 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102927: Consensus Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102927

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