510(k) · Cleared
ClearedProseries Bioimplants-Proankle/Procuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Orthopedic and Woundcare, Inc. · FTM Mesh, Surgical
Cleared on Oct 25, 2011 as substantially equivalent to K090288 (Pegasus Biologics, Inc., 2009) after a 29-day review. Its family tree reaches back 13 generations to 1993. 1 of the 106 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 25, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K931386 (1993). 100 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 1 citing it directly. 1 of the 106 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations between
- 3 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 2 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 1 generation backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- This deviceK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK251063 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025
- Descendant · 2 generations on · 1 of its ownK261621 TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 3 generations on · 0 of its ownK262729 TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026
- Descendant · 2 generations on · 0 of its ownK230671 Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 12 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 11 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 10 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 9 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 8 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 7 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 6 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 5 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 4 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 3 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 2 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 1 generation backK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- This deviceK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
Class I recalls in this family
- K963967 Glycar Pericardial Patch3 generations back · 1997
Most influential descendants
Showing 5 of 5 · See all- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · cites it directly4descendants
- K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2025 · 2 generations on2descendants
- K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 2 generations on1descendant
- K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro · 2026 · 3 generations on0descendants
- K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −12 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −11 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −10 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −9 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −8 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −7 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −6 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −5 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −4 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −3 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| −2 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| −1 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| 0 (this device) | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +1 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K251063 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2025 | — |
| +2 | K261621 | TekBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +3 | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | 2026 | — |
| +2 | K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 1 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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.
1 device in this family has a Class I recall. 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 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 |
|---|---|---|---|
| * | K090288 | Orthadapt PRSummary page 1…ification of Predicate Device The PROserieSTM Bioimplants - PROcufUN I1PROankeTM are substantially equivalent to the OrthADAPTqD PR Bioimplant, Pegasus Biologics, Inc., K090288. 4 Device Description PROseries Bicimplants are comprised of collagen matrix reinforced by a woven polymer to provide perm… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | 2022 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 10 of the 100 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220091 (Xiros, Ltd., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K090288.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
PROseriesTM Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles…
Read the full statement (125 words)
PROseriesTM Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
PROseries Bioimplants are not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112786 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112786: Proseries Bioimplants-Proankle/Procuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112786
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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