510(k) · Cleared
ClearedTGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexandria Research Technologies, LLC · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jul 23, 2010 as substantially equivalent to K040268 (DePuy Orthopaedics, Inc., 2004) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jul 23, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954481 (1996). 6 ancestors in all, the oldest K912735 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK954481 P.F.C. Uni-Compartmental Knee SystemJohnson & Johnson Professionals, Inc. · 1996
- 1 generation backK040268 Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc. · 2004 · Recalled
- This deviceK101206 TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954481 | P.F.C. Uni-Compartmental Knee System | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −1 | K040268 | Depuy Preservation Unicondylar Tibia | DePuy Orthopaedics, Inc. | 2004 | 10 |
| 0 (this device) | K101206 | TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia System | Alexandria Research Technologies, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K040268 | Depuy Preservation Unicondylar TibiaSummary page 1…constrained cemented prosthesis, Class 11 Product Device Code HSX, HRY Predicate Devices DePuy Preservation -Unicondylar Tibia (K040268, Cleared: May 5, 2004) Gienesis Unicompartmental Knee Syste… | 2004 |
| * | K912735 | Genesis Unicompartmental Knee SystemSummary page 1…5, 2004) Gienesis Unicompartmental Knee System (Accuris), Smith & Nephew (K9 12735, Cleared: December 27, 199 1) TGS® Unicompartmental Knee Arthroplasty System (K090024,… | 1991 |
| * | K090024 | TGS Unicompartmental Knee Arthroplasty SystemSummary page 1…th & Nephew (K9 12735, Cleared: December 27, 199 1) TGS® Unicompartmental Knee Arthroplasty System (K090024, Cleared: May 4, 2009) Device Description TGS®' Unicompartmental Knee Arthroplasty Modular Ti… | 2009 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040268.
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. 2010, 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 TGS® Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:
1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
2. Failed previous implant.
3. Correctable deformity.
4. All TGSO UKA System implants are intended for cemented use only.
5. Components of this system are designed for single use and to be used as a system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101206: TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101206
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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