510(k) · Cleared
ClearedBC Reflex Uni 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 Aug 20, 2021 as substantially equivalent to K203697 (Bodycad Laboratories, Inc., 2021) after a 60-day review. Its family tree reaches back 15 generations to 1992.
- Decided
- Aug 20, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K911802 (1992). 70 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 15 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 11 generations between
- 3 generations backK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- 2 generations backK191996 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019
- 1 generation backK203697 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
- This deviceK211895 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 14 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- 13 generations backK043570 Unicondylar Knee Repair System / Conformis UcdConformis, Inc. · 2005 · Recalled
- 12 generations backK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
- 11 generations backK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- 10 generations backK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- 9 generations backK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- 8 generations backK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
- 7 generations backK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
- 6 generations backK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
- 5 generations backK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- 4 generations backK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- 3 generations backK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- 2 generations backK191996 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019
- 1 generation backK203697 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
- This deviceK211895 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −14 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| −13 | K043570 | Unicondylar Knee Repair System / Conformis Ucd | Conformis, Inc. | 2005 | 3 |
| −12 | K053488 | Conformis Bicompartmental Knee Repair System | Conformis, Inc. | 2006 | — |
| −11 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| −10 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| −9 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| −8 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
| −7 | K121974 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2012 | — |
| −6 | K132640 | Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2013 | 3 |
| −5 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| −4 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| −3 | K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| −2 | K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| −1 | K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | — |
| 0 (this device) | K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K203697 | BC Reflex Uni Knee SystemSummary page 4…, cemented Classification Code: HSX – Class II Classification Panel: Orthopedic Regulation Number: 21 CFR section 888.3520 C1. PRIMARY PREDICATE DEVICE K203697 BC Reflex Uni™ Knee System (primary predicate device) C2. REFERENCE DEVICES K210252 ConforMI… | 2021 |
| † | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity… | 2021 |
| † | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | 2011 |
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 4 companies; a new generation was cleared every 1.2 years on median.
- 28 of the 70 ancestors have a recall of any class.
- 1 other device also cites its predicate K203697.
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 patient-specific BC Reflex Uni™ 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…
Read the full statement (105 words)
The patient-specific BC Reflex Uni™ 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 BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.
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/K211895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211895: BC Reflex Uni 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/K211895
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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