510(k) · Cleared
Recalled · Class II · 2014Stride Unicondylar Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Belt Technologies, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on May 31, 2013 as substantially equivalent to K033363 (Zimmer, Inc., 2004) and 1 other predicate after a 211-day review. Its family tree reaches back 5 generations to 1997. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- May 31, 2013
- Review
- 211 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971938 (1997). 18 ancestors in all, the oldest K880155 (1988). 11 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 4 generations backK020741 Unicondylar KneeEncore Orthopedics, Inc. · 2002 · Recalled
- 3 generations backK022437 Uni KneeEncore Medical L.P. · 2002 · Recalled
- 2 generations backK080368 Mako Surgical Corp. Unicondylar Knee Implant System IIMako Surgical Corp. · 2008
- 1 generation backK082081 Mako Surgical Corporation Unicondylar Knee Implant System IiiMako Surgical Corp. · 2008
- This deviceK123380 Stride Unicondylar KneeBlue Belt Technologies, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK191996 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK203697 BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · cites it directly8descendants
- K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 2 generations on7descendants
- K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 2 generations on4descendants
- K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2019 · 2 generations on3descendants
- K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −4 | K020741 | Unicondylar Knee | Encore Orthopedics, Inc. | 2002 | 2 |
| −3 | K022437 | Uni Knee | Encore Medical L.P. | 2002 | 2 |
| −2 | K080368 | Mako Surgical Corp. Unicondylar Knee Implant System II | Mako Surgical Corp. | 2008 | — |
| −1 | K082081 | Mako Surgical Corporation Unicondylar Knee Implant System Iii | Mako Surgical Corp. | 2008 | — |
| 0 (this device) | K123380 | Stride Unicondylar Knee | Blue Belt Technologies, Inc. | 2013 | — |
| +1 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| +2 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +2 | K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +2 | K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +3 | K203697 | 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 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 4 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 1…opedic PREDICATE DEVICES: The predicate devices for the STRIDE Unicondylar Knee are the Zimmer@ Unicompartmental Knee System, K033363 (cleared 1/16/2004); and the MAKO Surgical Corporation Unicondylar… | 2004 |
| * | K082081 | Mako Surgical Corporation Unicondylar Knee Implant System IiiSummary page 1…System, K033363 (cleared 1/16/2004); and the MAKO Surgical Corporation Unicondylar Knee Implant System Ill, K082081 (cleared 8/15/2008). Blue Belt Technologies, Inc. 4-17-2013… | 2008 |
What descends from it? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2014 | Class II | Z-1943-2014 | Labeling mix-ups | Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral. |
| Jun 4, 2014 | Class II | Z-1942-2014 | Labeling mix-ups | Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 9 of the 18 ancestors have a recall of any class.
- Of its descendants, K163700 (Bodycad Laboratories, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 21 other devices also cite its predicate K033363.
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. 2013, 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 STRIDE Unicondylar Knee devices are indicated for patients with:
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
These devices are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123380: Stride Unicondylar Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123380
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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