510(k) · Cleared
ClearedBodycad Unicompartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodycad Laboratories, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jan 17, 2019 as substantially equivalent to K163700 (Bodycad Laboratories, Inc., 2017) after a 245-day review. Its family tree reaches back 11 generations to 1992. 7 later devices descend from it.
- Decided
- Jan 17, 2019
- Review
- 245 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K911802 (1992). 66 ancestors in all, the oldest K880155 (1988). 7 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 7 generations between
- 3 generations backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- 2 generations backK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
- 1 generation backK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- This deviceK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK191996 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK203697 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Show all 11 generations
- Root · 11 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 10 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 9 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 8 generations backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- 7 generations backK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- 6 generations backK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- 5 generations backK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- 4 generations backK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- 3 generations backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- 2 generations backK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
- 1 generation backK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- This deviceK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · cites it directly4descendants
- K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019 · cites it directly3descendants
- K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021 · 2 generations on2descendants
- K203341ACS LD Uni FB Knee SystemImplantcast GmbH · 2021 · cites it directly1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −10 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −9 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −8 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| −7 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| −6 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| −5 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| −4 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| −3 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
| −2 | K132640 | Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2013 | 3 |
| −1 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| 0 (this device) | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +1 | K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +1 | K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +2 | K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | — |
| +1 | K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021 | — |
| +2 | 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 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 4 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K163700 | Bodycad Unicompartmental Knee SystemSummary page 4…Classification Panel: Orthopedic Regulation Number: 21 CFR section 888.3520 C. PREDICATE DEVICE K163700 The Bodycad Unicompartmental Knee System (Bodycad UKS) Bodycad UKS… | 2017 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 28 of the 66 ancestors have a recall of any class.
- Of its descendants, K191150 (Bodycad Laboratories, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K163700.
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. 2019, 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 patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with: • joint impairment due to osteoarthritis or traumatic arthritis of the knee, • varus deformity of the…
Read the full statement (120 words)
The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
• joint impairment due to osteoarthritis or traumatic arthritis of the knee,
• varus deformity of the knee, and
• as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. The Bodycad screws must be used for fixation of the femoral and tibial components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181302 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181302: Bodycad Unicompartmental 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/K181302
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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