510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Profix Total Knee System

K030623510(k) AbbreviatedCleared May 22, 200384-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

Smith & Nephew, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on May 22, 2003 as substantially equivalent to K933958 (Smith & Nephew Richards, Inc., 1995) and 4 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1986. 78 later devices descend from it.

Decided
May 22, 2003
Review
84 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K853730 (1986). 5 ancestors in all. 78 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1989: 1 other ancestor2004: 2 descendants cleared2012: 3 descendants cleared2010: 2 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared2021: 8 descendants cleared2006: 2 descendants cleared2014: 4 descendants cleared2008: 1 descendant cleared2017: 3 descendants cleared2023: 3 descendants cleared2013: 5 descendants cleared2015: 5 descendants cleared2020: 3 descendants cleared2019: 5 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2026: 8 descendants cleared2024: 9 descendants cleared2025: 6 descendants clearedK853730 · Freeman-Samuelson Mark II Press-Fit Total Knee Rep · Protek, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 27 descendants4 generations forward: 23 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants K853730 · Freeman-Samuelson Mark II Press-Fit Total Knee Rep · Protek, Inc. · 19860+5
  1. Root · 1 generation backK853730 Freeman-Samuelson Mark II Press-Fit Total Knee RepProtek, Inc. · 1986
  2. This deviceK030623 Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. Descendant · 2 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  5. Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. Descendant · cites it directly · 14 of its ownK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005
  7. Descendant · 2 generations on · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12006: 22008: 12010: 22011: 12012: 32013: 52014: 42015: 52016: 22017: 32018: 32019: 52020: 32021: 82022: 22023: 32024: 92025: 62026: 8
2004high 9 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 78 · See all
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 2 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
  • K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · cites it directly14descendants
  • K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · 2 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853730Freeman-Samuelson Mark II Press-Fit Total Knee RepProtek, Inc.1986—
0 (this device)K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.2003—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
+1K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199510
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200620
200810
201020
201110
201230
201350
201440
201550
201620
201730
201830
201950
202030
202180
202220
202330
202490
202560
202680
FIG. 1 — Lineage of K030623, 1986–2026Source: 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 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 20.0 · 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? (5)

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
*K933958Richards Total Knee System
Summary page 1
…l Knee System is substantially equivalent to the currently marketed knee prosthesis filed with the following premarket notifications: Profix Total Knee System (K933958), Profix Posterior-Stabilized Knee System (K954909), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255), Tricon K…
Smith & Nephew Richards, Inc.1995—
*K954909Profix Posterior-Stabilized Knee System
Summary page 1
…he currently marketed knee prosthesis filed with the following premarket notifications: Profix Total Knee System (K933958), Profix Posterior-Stabilized Knee System (K954909), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255), Tricon Knee System (K884824), and Freeman-Samuelson Ma…
Smith & Nephew Richards, Inc.1996—
*K963255Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert
Summary page 1
…rket notifications: Profix Total Knee System (K933958), Profix Posterior-Stabilized Knee System (K954909), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255), Tricon Knee System (K884824), and Freeman-Samuelson Mark I1 Press-Fit Total Knee Replacement (K853730) D. SUMMARY O F T…
Smith & Nephew, Inc., Orthopaedic Div.1997—
*K884824Tricon-M Total Knee System
Summary page 1
…x Total Knee System (K933958), Profix Posterior-Stabilized Knee System (K954909), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255), Tricon Knee System (K884824), and Freeman-Samuelson Mark I1 Press-Fit Total Knee Replacement (K853730) D. SUMMARY O F TECHNOLOGICAL COMPARISON:…
Richards Medical Co., Inc.1989—
*K853730Freeman-Samuelson Mark II Press-Fit Total Knee Rep
Summary page 1
…), Profix Knee Posterior-Stabilized Plus Tibial Insert (K963255), Tricon Knee System (K884824), and Freeman-Samuelson Mark I1 Press-Fit Total Knee Replacement (K853730) D. SUMMARY O F TECHNOLOGICAL COMPARISON: The intended use, designs, and materials of the Profix Total Knee System are su…
Protek, Inc.1986—

Also cleared against K933958: 2 other devices →

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460
K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.200514
K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012
K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.20125
K102927Consensus Knee SystemConsensus 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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K033489 (Biomet, Inc., 2004) has gone furthest, with 60 descendants of its own.
  • 2 other devices also cite its predicate K933958.

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.

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 Profix Total Knee System is indicated for:

1. Rheumatoid arthntis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-tern result.

3. Failed osteotomies, unicornpartmental replacement, or total knee replacement.

4. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Profix Total Knee System includes porous coated devices which are indicated for use without bone cement, and are single use devices.

Indications for use as stated in the FDA summary.

Also cleared against K933958

2 other devices cite the same predicate.

  • K080199Symmetric Total Knee SystemSignal Medical Corporation · 20081 recall
  • K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K030623 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030623: Smith & Nephew Profix Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030623

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