510(k) · Cleared
ClearedTahoe Unicondylar Knee System with TiNbN Overcoat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Apr 2, 2026 as substantially equivalent to K170344 (Consensus Orthopedics, Inc., 2017) and 3 other predicates after a 22-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Apr 2, 2026
- Review
- 22 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K971938 (1997). 66 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 6 generations backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
- 5 generations backK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
- 4 generations backK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
- 3 generations backK082081 Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp. · 2008
- 2 generations backK123380 Stride Unicondylar KneeBlue Belt Technologies, Inc. · 2013 · Recalled
- 1 generation backK170344 Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
- This deviceK260796 Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −6 | K020741 | Unicondylar Knee | Encore Orthopedics, Inc. | 2002 | 2 |
| −5 | K022437 | Uni Knee | Encore Medical L.P. | 2002 | 2 |
| −4 | K080368 | Mako Surgical Corp. Unicondylar Knee Implant System II | Mako Surgical Corp. | 2008 | — |
| −3 | K082081 | Mako Surgical Corporation Unicondylar Knee Implant System Iii | Mako Surgical Corp. | 2008 | — |
| −2 | K123380 | Stride Unicondylar Knee | Blue Belt Technologies, Inc. | 2013 | 2 |
| −1 | K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K260796 | Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
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 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170344 | Tahoe Uni Knee SystemSummary page 5…non-constrained cemented prosthesis Regulation Number: 888.3520 Product Code(s): HSX Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) Primary Predicate #: K170344, Tahoe Unicondylar Knee System, Product Code HSX Additional Predicate #: K241180, Consensus Knee System with TiNbN, Product Code… | 2017 |
| * | K241180 | Consensus Knee System with TiNbNSummary page 5…: HSX Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) Primary Predicate #: K170344, Tahoe Unicondylar Knee System, Product Code HSX Additional Predicate #: K241180, Consensus Knee System with TiNbN, Product Code JWH; K122239, Foundation, Foundation – PS, 3D-Knee, Product Code JWH; K182251, EV… | 2025 |
| * | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Summary page 5…(3)) Primary Predicate #: K170344, Tahoe Unicondylar Knee System, Product Code HSX Additional Predicate #: K241180, Consensus Knee System with TiNbN, Product Code JWH; K122239, Foundation, Foundation – PS, 3D-Knee, Product Code JWH; K182251, EVOLUTION NitrX Medial-Pivot Knee, Product Code JWH Device D… | 2013 |
| * | K182251 | EVOLUTION NitrX Medial-Pivot KneeSummary page 5…, Product Code HSX Additional Predicate #: K241180, Consensus Knee System with TiNbN, Product Code JWH; K122239, Foundation, Foundation – PS, 3D-Knee, Product Code JWH; K182251, EVOLUTION NitrX Medial-Pivot Knee, Product Code JWH Device Description Summary (21 CFR 807.92(a)(4)): The Tahoe Unicondylar… | 2019 |
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 29 years and passes through 7 companies; a new generation was cleared every 4.6 years on median.
- 34 of the 66 ancestors have a recall of any class.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Tahoe Unicondylar 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…
Read the full statement (107 words)
The Tahoe Unicondylar 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 (TiNbN coated and uncoated) are single use only and are intended for implantation only with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260796
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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