510(k) Report

510(k) · Cleared

Cleared

Tahoe Uni Knee System

K170344510(k) TraditionalCleared Oct 5, 2017244-day reviewClass II21 CFR 888.3520

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

Consensus Orthopedics, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Oct 5, 2017 as substantially equivalent to K050764 (Corin USA, 2005) and 6 other predicates after a 244-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.

Decided
Oct 5, 2017
Review
244 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K971938 (1997). 25 ancestors in all, the oldest K880155 (1988). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 3 other ancestors2002: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors1998: 1 other ancestor1996: 3 other ancestors1988: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2003: 1 other ancestor1993: 1 other ancestor2026: 1 descendant clearedK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled×2: 2 generations cleared close together, K020741 (2002), K022437 (2002) ×2: 2 generations cleared close together, K080368 (2008), K082081 (2008) K123380 · Stride Unicondylar Knee · Blue Belt Technologies, Inc. · 2013 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant K123380 · Stride Unicondylar Knee · Blue Belt Technologies, Inc. · 2013 · recalledK082081 · Mako Surgical Corporation Unicondylar Knee Implant System Iii · Mako Surgical Corp. · 2008K080368 · Mako Surgical Corp. Unicondylar Knee Implant System II · Mako Surgical Corp. · 2008K022437 · Uni Knee · Encore Medical L.P. · 2002 · recalledK020741 · Unicondylar Knee · Encore Orthopedics, Inc. · 2002 · recalledK971938 · Repicci II Unicondylar Knee · Biomet, Inc. · 1997 · recalled−50
  1. Root · 6 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
  2. 5 generations backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
  3. 4 generations backK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
  4. 3 generations backK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
  5. 2 generations backK082081 Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp. · 2008
  6. 1 generation backK123380 Stride Unicondylar KneeBlue Belt Technologies, Inc. · 2013 · Recalled
  7. This deviceK170344 Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  8. Descendant · cites it directly · 0 of its ownK260796 Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K971938Repicci II Unicondylar KneeBiomet, Inc.19971
−5K020741Unicondylar KneeEncore Orthopedics, Inc.20022
−4K022437Uni KneeEncore Medical L.P.20022
−3K080368Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp.2008—
−2K082081Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp.2008—
−1K123380Stride Unicondylar KneeBlue Belt Technologies, Inc.20132
0 (this device)K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc.2017—
+1K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199630
199810
199920
200130
200210
200310
200430
200510
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K170344, 1997–2026Source: 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 HSX? 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 HSX device

  1. #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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
*K050764Uniglide Unicondylar Knee Prosthesis
Summary page 5
…stantially equivalent to the following unicompartmental knee systems intended for cemented use: • Uniglide - Femoral component used with all-poly tibial component (K050764). • Oxford - Femoral component used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed ti…
Corin USA2005—
*K971938Repicci II Unicondylar Knee
Summary page 5
…ms intended for cemented use: • Uniglide - Femoral component used with all-poly tibial component (K050764). • Oxford - Femoral component used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022…
Biomet, Inc.19971
*K021621Fixed Bearing Uni Component
Summary page 5
…Uniglide - Femoral component used with all-poly tibial component (K050764). • Oxford - Femoral component used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022437; K020741). • Stride - Metal-b…
Biomet, Inc.2002—
*K042093Vanguard M Series Unicondylar Tibial Bearings
Summary page 5
…- Femoral component used with all-poly tibial component (K050764). • Oxford - Femoral component used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022437; K020741). • Stride - Metal-backed tib…
Biomet, Inc.20042
*K022437Uni Knee
Summary page 5
…oral component used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022437; K020741). • Stride - Metal-backed tibial component (K123380). Non-Clinical Performance Data: Bench testing, FEA simulation…
Encore Medical L.P.20022
*K020741Unicondylar Knee
Summary page 5
…onent used with Repicci II (K971938) or Vanguard M Series (K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022437; K020741). • Stride - Metal-backed tibial component (K123380). Non-Clinical Performance Data: Bench testing, FEA simulations, and en…
Encore Orthopedics, Inc.20022
*K123380Stride Unicondylar Knee
Summary page 5
…(K021621, K042093) metal-backed tibial components. • EPIK - Metal-backed tibial component (K022437; K020741). • Stride - Metal-backed tibial component (K123380). Non-Clinical Performance Data: Bench testing, FEA simulations, and engineering justifications were carried out on TUKS implant…
Blue Belt Technologies, Inc.20132

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260

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 20 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
  • 13 of the 25 ancestors have a recall of any class.
  • Of its descendants, K260796 (Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics, 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HSX

4in 2025

2007: 62008: 42009: 22010: 32011: 12012: 52013: 22015: 12016: 32017: 52018: 22019: 72020: 42021: 72022: 22023: 12024: 42025: 42026 (partial year): 2
2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007: 33 days median2008: 102 days median2010: 74 days median2012: 88 days median2016: 147 days median2017: 160 days median2019: 90 days median2020: 40 days median2021: 81 days median2024: 133 days median2025: 59 days median
2007high 160 (2017) · low 33 (2007)2026

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

Recalls per year · HSX

2in 2020

2009: 492013: 12016: 12017: 42020: 2
2007high 49 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSX

175in 2025

2007: 62008: 42009: 212010: 582011: 1142012: 832013: 792014: 662015: 572016: 1072017: 1132018: 1592019: 1772020: 2732021: 2402022: 2572023: 2312024: 1722025: 175
2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, 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
200763306
2008410204
20092—4921
2010374058
20111—0114
2012588083
20132—179
20140—066
20151—057
201631471107
201751604113
20182—0159
20197900177
20204402273
20217810240
20222—0257
20231—0231
202441330172
20254590175
20262—0—

What is it indicated for?

The Tahoe Uni Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows: Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) post-traumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical…

Read the full statement (103 words)

The Tahoe Uni Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows:

Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) post-traumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial, collateral, and lateral collateral ligaments are present and functional.

All TUKS implants are single use only, and are intended for implantation only with bone cement.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Consensus Orthopedics, Inc.

17 FDA decisions under this applicant name. See the company

  • 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
  • K141043CS2 Multi-Hole Acetabular ShellConsensus Orthopedics, Inc. · 2014

Recent decisions in HSX

The HSX category page

  • K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
  • K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
  • K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
  • K251834Persona Partial KneeZimmer Biomet · 2025
  • K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025

https://510kreport.com/device/K170344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170344: Tahoe Uni 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/K170344

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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