510(k) Report

510(k) · Cleared

Cleared

Freeman-Samuelson Mark II Press-Fit Total Knee Rep

K853730510(k) TraditionalCleared Feb 18, 1986165-day reviewClass II21 CFR 888.3560

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

Protek, Inc. · MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Cleared on Feb 18, 1986 after a 165-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.

Decided
Feb 18, 1986
Review
165 days
Class
Class II
Product code
MBV
Recalls
None
Predicates
0

81 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2002: 1 descendant cleared2014: 5 descendants cleared2004: 2 descendants cleared2012: 3 descendants cleared2010: 2 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared2021: 8 descendants cleared2006: 2 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 cleared1990200020102020
  1. This deviceK853730 Freeman-Samuelson Mark II Press-Fit Total Knee RepProtek, Inc. · 1986
  2. Descendant · cites it directly · 78 of its ownK030623 Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc. · 2003
  3. Descendant · 2 generations on · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
  4. Descendant · 3 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
  5. Descendant · 3 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. Descendant · 2 generations on · 14 of its ownK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22005: 12006: 22008: 12010: 22011: 12012: 32013: 52014: 52015: 52016: 22017: 32018: 32019: 52020: 32021: 82022: 22023: 32024: 92025: 62026: 8
2002high 9 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 81 · See all
  • K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc. · 2003 · cites it directly78descendants
  • K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · 2 generations on60descendants
  • K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 3 generations on47descendants
  • K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 3 generations on46descendants
  • K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853730Freeman-Samuelson Mark II Press-Fit Total Knee RepProtek, Inc.1986—
+1K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.2003—
+2K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…Biomet, Inc.2004—
+3K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp2006—
+3K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp20127
+2K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
200510
200620
200810
201020
201110
201230
201350
201450
201550
201620
201730
201830
201950
202030
202180
202220
202330
202490
202560
202680
FIG. 1 — Lineage of K853730, 1986–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MBV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K030623Smith & Nephew Profix Total Knee SystemSmith & Nephew, Inc.200378
K020214Medial Rotation Knee SystemEngineering Consulting Services, Inc.20021

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?

  • Of its descendants, K030623 (Smith & Nephew, Inc., 2003) has gone furthest, with 78 descendants of its own.

How does its category compare?

All MBV devices

MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBV

FDA has decided no MBV device since 2007.

Median 510(k) review, days · MBV

Too few MBV 510(k)s in any year since 2007 to give a median.

Recalls per year · MBV

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · MBV

3in 2024

2009: 22011: 112012: 122013: 152014: 52015: 182016: 42017: 132018: 52019: 162020: 102021: 12022: 62023: 72024: 3
2007high 18 (2015) · low 0 (2007)2025

MAUDE reports naming product code MBV, 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
20070—00
20080—00
20090—02
20100—00
20110—011
20120—112
20130—015
20140—05
20150—018
20160—04
20170—013
20180—05
20190—016
20200—010
20210—01
20220—06
20230—07
20240—03
20250—00
20260—0—

More from Protek, Inc.

25 FDA decisions under this applicant name. See the company

  • K893785Arc-2F Acetabular CupProtek, Inc. · 1989
  • K893959P.S.a. Femoral Hip ProsthesisProtek, Inc. · 1989
  • K892059Femoral Heads/Modular & Fixed W/ Titan Nitride SurProtek, Inc. · 1989
  • K883794Resubmitted CLW Acetabular Cup W/SulmeshProtek, Inc. · 1989
  • K884952Various Femoral Hip Prostheses W/Self Lock CeramicProtek, Inc. · 1989

Recent decisions in MBV

The MBV category page

  • K010212Offset Tibial TrayBiomet, Inc. · 20013 recalls
  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989
  • K873429Freeman-Samuelson Mark II Press-Fit Total KneeProtek, Inc. · 1987
  • K833200Tricon M Total Knee SystemRichards Medical Co., Inc. · 1983
  • K831441Porocoat Freeman/Samuelson Total KneeDepuy, Inc. · 1983

https://510kreport.com/device/K853730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K853730: Freeman-Samuelson Mark II Press-Fit Total Knee Rep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853730

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026