510(k) · Cleared
ClearedThe BioBrace Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biorez, Inc. · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Apr 30, 2021 as substantially equivalent to K121216 (Soft Tissue Regeneration, Inc., 2012) after a 176-day review. Its family tree reaches back 11 generations to 1992. 4 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 176 days
- Class
- Class II
- Product code
- OWW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921895 (1992). 38 ancestors in all, the oldest K810428 (1981). 4 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 2 generations backK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- 1 generation backK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- This deviceK203267 The BioBrace ImplantBiorez, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK241906 BioBrace® Reinforced ImplantConmed Corporation · 2024
- Descendant · cites it directly · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK250395 BioBrace ® RC Delivery SystemConmed Corporation · 2025
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK052830 SportmeshArtimplant AB · 2006
- 3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 2 generations backK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- 1 generation backK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- This deviceK203267 The BioBrace ImplantBiorez, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K241906BioBrace® Reinforced ImplantConmed Corporation · 2024 · cites it directly3descendants
- K242187BioBrace®Conmed Corporation · 2024 · cites it directly1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 2 generations on0descendants
- K250395BioBrace ® RC Delivery SystemConmed Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −3 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −2 | K083307 | Synthasome X-Repair | Synthasome, Inc. | 2009 | — |
| −1 | K121216 | STR Graft | Soft Tissue Regeneration, Inc. | 2012 | — |
| 0 (this device) | K203267 | The BioBrace Implant | Biorez, Inc. | 2021 | — |
| +1 | K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024 | — |
| +1 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +2 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +2 | K250395 | BioBrace ® RC Delivery System | Conmed Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 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 |
|---|---|---|---|
| * | K121216 | STR GraftSummary page 4…OWW and OWY Classification Panel: General and Plastic Surgery Devices Regulation Number: 21 CFR sections 878.3300 C1. PRIMARY PREDICATE DEVICE K121216 Soft Tissue Regeneration’s STR GRAFT C2. REFERENCE DEVICES K112423 Rotation Medical’… | 2012 |
| † | K112423 | Collagen Tendon Sheet | 2011 |
| † | K071887 | Sportmesh or Artelon Tissue Reinforcement | 2007 |
| † | K192112 | FlexBand Plus | 2019 |
| † | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM… | 2004 |
What descends from it? (4)
2 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 29 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 38 ancestors has a recall of any class.
- Of its descendants, K241906 (Conmed Corporation, 2024) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the…
Read the full statement (106 words)
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
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/K203267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203267: The BioBrace Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203267
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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