510(k) · Cleared
ClearedACS LD Uni FB Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implantcast GmbH · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jan 8, 2021 as substantially equivalent to K063515 (Biomet Manufacturing, Inc., 2007) and 4 other predicates after a 57-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it.
- Decided
- Jan 8, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K911802 (1992). 72 ancestors in all, the oldest K880155 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 8 generations between
- 3 generations backK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
- 2 generations backK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- 1 generation backK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- This deviceK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
- Descendant · cites it directly · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Show all 12 generations
- Root · 12 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 11 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 10 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 9 generations backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- 8 generations backK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- 7 generations backK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- 6 generations backK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- 5 generations backK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- 4 generations backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- 3 generations backK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
- 2 generations backK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- 1 generation backK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- This deviceK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
Most influential descendants
Showing 1 of 1 · See all- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −11 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −10 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −9 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| −8 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| −7 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| −6 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| −5 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| −4 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
| −3 | K132640 | Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2013 | 3 |
| −2 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| −1 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| 0 (this device) | K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021 | — |
| +1 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeSummary page 4…osthesis Class: II Product Code: HSX Predicate Devices: Biomet Repicci II® Unicondylar Knee (K063515) Bodycad Unicompartmental Knee System (K163700, K181302)… | 2007 |
| * | K163700 | Bodycad Unicompartmental Knee SystemSummary page 4…HSX Predicate Devices: Biomet Repicci II® Unicondylar Knee (K063515) Bodycad Unicompartmental Knee System (K163700, K181302) Medacta GMK® UNI (K161741) Zimmer Unicompar… | 2017 |
| * | K181302 | Bodycad Unicompartmental Knee SystemSummary page 4…Predicate Devices: Biomet Repicci II® Unicondylar Knee (K063515) Bodycad Unicompartmental Knee System (K163700, K181302) Medacta GMK® UNI (K161741) Zimmer Unicompartmental K… | 2019 |
| * | K161741 | GMK UniSummary page 4…ylar Knee (K063515) Bodycad Unicompartmental Knee System (K163700, K181302) Medacta GMK® UNI (K161741) Zimmer Unicompartmental Knee System (K033363) Indications for Use: The AC… | 2017 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 4…nee System (K163700, K181302) Medacta GMK® UNI (K161741) Zimmer Unicompartmental Knee System (K033363) Indications for Use: The ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating su… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260037 | implantcast Packaging System Update | 2026 | 0 |
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 5 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 72 ancestors have a recall of any class.
- Of its descendants, K260037 (Implantcast GmbH, 2026) has gone furthest, with 0 descendants of its own.
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. 2021, 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 ACS® LD Uni FB Knee System is indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
This device is single-use implant intended for implantation 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.
https://510kreport.com/device/K203341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203341: ACS LD Uni FB Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203341
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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