510(k) · Cleared
ClearedBioBrace ® RC Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · ORQ Mesh, Surgical, Deployer
Cleared on Apr 7, 2025 as substantially equivalent to K241906 (Conmed Corporation, 2024) after a 54-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Apr 7, 2025
- Review
- 54 days
- Class
- Class II
- Product code
- ORQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K921895 (1992). 40 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations between
- 3 generations backK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- 2 generations backK203267 The BioBrace ImplantBiorez, Inc. · 2021
- 1 generation backK241906 BioBrace® Reinforced ImplantConmed Corporation · 2024
- This deviceK250395 BioBrace ® RC Delivery SystemConmed Corporation · 2025
Show all 13 generations
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 12 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 10 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 9 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 8 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 7 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 6 generations backK052830 SportmeshArtimplant AB · 2006
- 5 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 4 generations backK083307 Synthasome X-RepairSynthasome, Inc. · 2009
- 3 generations backK121216 STR GraftSoft Tissue Regeneration, Inc. · 2012
- 2 generations backK203267 The BioBrace ImplantBiorez, Inc. · 2021
- 1 generation backK241906 BioBrace® Reinforced ImplantConmed Corporation · 2024
- This deviceK250395 BioBrace ® RC Delivery SystemConmed Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −12 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −10 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −9 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −7 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −6 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −5 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −4 | K083307 | Synthasome X-Repair | Synthasome, Inc. | 2009 | — |
| −3 | K121216 | STR Graft | Soft Tissue Regeneration, Inc. | 2012 | — |
| −2 | K203267 | The BioBrace Implant | Biorez, Inc. | 2021 | — |
| −1 | K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024 | — |
| 0 (this device) | 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 |
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 ORQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K241906 | BioBrace® Reinforced ImplantSummary page 5…ulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW, OWY 510K#: K241906 K250395 Page 2/3 IV. DEVICE DESCR… | 2024 |
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 33 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 40 ancestors has a recall of any class.
- 1 other device also cites its predicate K241906.
How does its category compare?
All ORQ devicesORQ Mesh, Surgical, Deployer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ORQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ORQ
Too few ORQ 510(k)s in any year since 2007 to give a median.
Recalls per year · ORQ
No recall names ORQ since 2007.
Adverse event reports per year · ORQ
11in 2025
MAUDE reports naming product code ORQ, 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 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used…
Read the full statement (111 words)
The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. 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.
The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250395: BioBrace ® RC Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250395
Report an extraction error
Are you the manufacturer?
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