510(k) Report

510(k) · Cleared

Cleared

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

K162256510(k) TraditionalCleared Oct 27, 201677-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

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

Cleared on Oct 27, 2016 as substantially equivalent to K112906 (Total Joint Orthopedics, Inc., 2012) and 3 other predicates after a 77-day review. Its family tree reaches back 9 generations to 1994. 1 of the 55 devices in its family, counting itself, has a Class I recall.

Decided
Oct 27, 2016
Review
77 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K936079 (1994). 54 ancestors in all, the oldest P830055 (1985). No later device cites it as a predicate yet. 1 of the 55 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2013: 1 other ancestor2012: 1 other ancestor2006: 2 other ancestors, 1 with a Class I recall12009: 1 other ancestor2007: 1 other ancestor2005: 2 other ancestors2000: 3 other ancestors1995: 8 other ancestors1993: 2 other ancestors1991: 2 other ancestors2008: 1 other ancestor2004: 2 other ancestors2003: 4 other ancestors2002: 2 other ancestors1997: 2 other ancestors1996: 3 other ancestors1994: 4 other ancestors1987: 1 other ancestor1985: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestorK936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K032606 · Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components · Exactech, Inc. · 2003K033883 · Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi · Exactech, Inc. · 2004 · recalledK093360 · Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T · Exactech, Inc. · 2010 · recalledK111400 · Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component · Exactech, Inc. · 2011 · recalledK121307 · Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz · Exactech, Inc. · 2012K123687 · Optetrak Logic Porous Femoral Component · Exactech, Inc. · 2013K153776 · Optetrak One Logic Femoral Components · Exactech, Inc. · 20161985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors, 1 with a Class I recall12 generations back: 9 other ancestors3 generations back: 24 other ancestors4 generations back: 7 other ancestors5 generations back: 2 other ancestors K153776 · Optetrak One Logic Femoral Components · Exactech, Inc. · 2016K123687 · Optetrak Logic Porous Femoral Component · Exactech, Inc. · 2013K121307 · Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak Logic CR Femoral Component, Siz · Exactech, Inc. · 2012K111400 · Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component · Exactech, Inc. · 2011 · recalledK093360 · Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T · Exactech, Inc. · 2010 · recalledK033883 · Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi · Exactech, Inc. · 2004 · recalledK032606 · Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components · Exactech, Inc. · 2003K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994−50
  1. Root · 9 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 5 generations between
  3. 3 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
  4. 2 generations backK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
  5. 1 generation backK153776 Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
  6. This deviceK162256 Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. · 2016
Show all 9 generations
  1. Root · 9 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 8 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 7 generations backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
  4. 6 generations backK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004 · Recalled
  5. 5 generations backK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
  6. 4 generations backK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
  7. 3 generations backK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
  8. 2 generations backK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
  9. 1 generation backK153776 Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
  10. This deviceK162256 Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. · 2016

Class I recalls in this family

  • K061223 Advance Total Knee Systemdirect predicate · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−8K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−7K032606Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc.2003—
−6K033883Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…Exactech, Inc.20043
−5K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc.20102
−4K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc.20111
−3K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size…Exactech, Inc.2012—
−2K123687Optetrak Logic Porous Femoral ComponentExactech, Inc.2013—
−1K153776Optetrak One Logic Femoral ComponentsExactech, Inc.2016—
0 (this device)K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
199120
199320
199440
199580
199630
199720
199910
200030
200110
200220
200340
200420
200520
200621
200710
200810
200910
201210
201310
FIG. 1 — Lineage of K162256, 1994–2016Source: 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.

1 device in this family has a Class I recall. 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? (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
*K112906Klassic Knee System
Summary page 5
…intered coating for uncemented biologic fixation. Predicate Devices: The Klassic® Femur, Porous is substantially equivalent to the predicate Klassic® Knee System Femur (K112906) with respect to material, design, and function. The Klassic® Femur, Porous is substantially equivalent to the Exactech® Optetrak…
Total Joint Orthopedics, Inc.2012—
*K153776Optetrak One Logic Femoral Components
Summary page 5
…906) with respect to material, design, and function. The Klassic® Femur, Porous is substantially equivalent to the Exactech® Optetrak One Logic Porous Femoral Component (K153776) and the Wright Medical Advance® Total Knee System porous coated Femoral Components (K061223) with regards to material, function…
Exactech, Inc.2016—
*K061223Advance Total Knee System
Summary page 5
…lly equivalent to the Exactech® Optetrak One Logic Porous Femoral Component (K153776) and the Wright Medical Advance® Total Knee System porous coated Femoral Components (K061223) with regards to material, function and indications for use without bone cement. The Klassic® Tibial Baseplate, Porous is substa…
Wrightmedicaltechnologyinc2006Class I
*K123486Triathlon Tritanium Tibial Baseplate
Summary page 5
…aterial, design, and function. The Klassic® Tibial Baseplate, Porous is substantially equivalent to the Howmedica Osteonics Corp. Triathlon® Tritanium Tibial Baseplates (K123486) and the Wright Medical Advance® Total Knee System porous coated Tibial Component (K061223) with regards to material, function an…
Stryker20137

Also cleared against K112906: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K061223Advance Total Knee SystemWrightmedicaltechnologyinc · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls

What does this lineage say?

  • The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 39 of the 54 ancestors have a recall of any class; 1 has a Class I recall.
  • 11 other devices also cite its predicate K112906.

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. 2016, 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 Klassic® Knee System is intended for prosthetic replacement in treatment of the following: • Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis • Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis • Patients with failed previous surgery where pain, deformity, or dysfunction persists • Correctable varus-valgus deformity and moderate flexion contracture • Revision…

Read the full statement (101 words)

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:

• Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis

• Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis

• Patients with failed previous surgery where pain, deformity, or dysfunction persists

• Correctable varus-valgus deformity and moderate flexion contracture

• Revision of a previously failed knee arthroplasty

• Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Indications for use as stated in the FDA summary.

Also cleared against K112906

11 other devices cite the same predicate.

  • K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc. · 2025
  • K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc. · 2023
  • K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc. · 2023
  • K211602Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2021
  • K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic…Total Joint Orthopedics, Inc. · 2019
  • K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc. · 2018

More from Total Joint Orthopedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc. · 2026
  • K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc. · 2022
  • K211877Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2022
  • K211602Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2021
  • K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc. · 2020

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/K162256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162256: Klassic Femur, Porous, Klassic Tibial Baseplate, Porous.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162256

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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