510(k) · Cleared
ClearedVersaTap, VersaLat, DueLock, VersaTi, MiniTi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Design (Pty), Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 6, 2021 as substantially equivalent to K120942 (Parcus Medical, LLC, 2012) and 13 other predicates after a 126-day review. Its family tree reaches back 12 generations to 1991. 1 later device descends from it.
- Decided
- Dec 6, 2021
- Review
- 126 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 12 generations to K911837 (1991). 188 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 8 generations between
- 3 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 2 generations backK111000 Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011
- 1 generation backK201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020
- This deviceK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002)…Ortho-Design (Pty), Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 11 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 10 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 9 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 8 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 7 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 6 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 5 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 4 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 3 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 2 generations backK111000 Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011
- 1 generation backK201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020
- This deviceK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −11 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −10 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −9 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −8 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −7 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −6 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −5 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −4 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −3 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| −2 | K111000 | Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor | Parcus Medical, LLC | 2011 | — |
| −1 | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Parcus Medical, LLC | 2020 | — |
| 0 (this device) | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +1 | K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™… | Ortho-Design (Pty), Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 13 | 0 |
| 1997 | 14 | 0 |
| 1998 | 10 | 0 |
| 1999 | 15 | 0 |
| 2000 | 11 | 0 |
| 2001 | 13 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (15)
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 |
|---|---|---|---|
| * | K120942 | Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus…Summary page 5…21 CFR 888.3040 Device Classification: Class II Product Code: MBI Primary Predicate Device: Parcus Twist PEEK Suture Anchor (K120942) Secondary Predicates: Arthrex FT Suture Anchor (K061665) Arthrex 6.5mm x 14.7mm PEEK… | 2012 |
| * | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTSummary page 5…Product Code: MBI Primary Predicate Device: Parcus Twist PEEK Suture Anchor (K120942) Secondary Predicates: Arthrex FT Suture Anchor (K061665) Arthrex 6.5mm x 14.7mm PEEK Corkscrew FT Suture Anchor (K173788) Reference Devices:… | 2006 |
| * | K173788 | Arthrex Corkscrew FTSummary page 5…or (K120942) Secondary Predicates: Arthrex FT Suture Anchor (K061665) Arthrex 6.5mm x 14.7mm PEEK Corkscrew FT Suture Anchor (K173788) Reference Devices: K063453, K130274, K070758 Device description: The VersaTap™ Suture Anchor is a self-tapping… | 2018 |
| * | K130917 | Healix Advance Knotless BR AnchorSummary page 8…CFR 888.3040 Device Classification: Class II Product Code: MBI Primary Predicate Device: DePuy Mitek Healix Advance Knotless BR Anchor (K130917) Secondary Predicates: Arthrex Swivelock (K190728) Arthex Swivelock SP 5.5 x 24.5mm –… | 2013 |
| * | K190728 | Arthrex SwiveLock AnchorsSummary page 8…Code: MBI Primary Predicate Device: DePuy Mitek Healix Advance Knotless BR Anchor (K130917) Secondary Predicates: Arthrex Swivelock (K190728) Arthex Swivelock SP 5.5 x 24.5mm – AR-2323SLM (K203495) Reference devices: K1302… | 2019 |
| * | K203495 | Arthrex SwiveLock AnchorSummary page 8…Knotless BR Anchor (K130917) Secondary Predicates: Arthrex Swivelock (K190728) Arthex Swivelock SP 5.5 x 24.5mm – AR-2323SLM (K203495) Reference devices: K130274, K070758 Device description: The VersaLat™ Suture Anchor is an innovative knotless-/… | 2021 |
| * | K201786 | Arthrex Mini Hip PushLockSummary page 10…21 CFR 888.3040 Device Classification: Class II Product Code: MBI Primary Predicate Device: Arthrex PEEK Mini Pushlock Anchor (K201786) Secondary Predicates: Arthrex PEEK Pushlock (K101679) Parcus Knotless PEEK CF Pu… | 2020 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 10…uct Code: MBI Primary Predicate Device: Arthrex PEEK Mini Pushlock Anchor (K201786) Secondary Predicates: Arthrex PEEK Pushlock (K101679) Parcus Knotless PEEK CF Push-in 3.5 x 10mm – 10313 (K193295)… | 2010 |
| * | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorSummary page 10…nchor (K201786) Secondary Predicates: Arthrex PEEK Pushlock (K101679) Parcus Knotless PEEK CF Push-in 3.5 x 10mm – 10313 (K193295) Smith and Nephew 2.9mm BioRaptor (K121018) Reference Devices: K130274, K0707… | 2020 |
| * | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSummary page 10…679) Parcus Knotless PEEK CF Push-in 3.5 x 10mm – 10313 (K193295) Smith and Nephew 2.9mm BioRaptor (K121018) Reference Devices: K130274, K070758… | 2012 |
| * | K050358 | Artherx Corkscrew FT II Suture AnchorSummary page 13…21 CFR 888.3040 Device Classification: Class II Product Code: MBI Primary Predicate Device: Arthrex corkscrew™ FT ll Anchor (K050358) = Parcus V-Lox 4.5 x 13.9mm – 10353T (K201083) Reference Devices: K063456, K130… | 2005 |
| * | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsSummary page 13…MBI Primary Predicate Device: Arthrex corkscrew™ FT ll Anchor (K050358) = Parcus V-Lox 4.5 x 13.9mm – 10353T (K201083) Reference Devices: K063456, K130274 Device description: The VersaTi™ Suture Anchor is a self-tapping suture a… | 2020 |
| * | K071257 | Mini Quickanchor and Quickanchor Plus with OrthocordSummary page 16…21 CFR 888.3040 Device Classification: Class II Product Code: MBI Primary Predicate Device: De Puy Mitek MiniLok QuickAnchor (K071257) Secondary Predicates: Parcus Medical MiTi (K111000) Arthrex 2.2mm Micro Corkscrew FT… | 2007 |
| * | K111000 | Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorSummary page 16…II Product Code: MBI Primary Predicate Device: De Puy Mitek MiniLok QuickAnchor (K071257) Secondary Predicates: Parcus Medical MiTi (K111000) Arthrex 2.2mm Micro Corkscrew FT Suture Anchor (K173788) Rejoi… | 2011 |
| * | — | Rejoin Medical 2mm Ti Anchor Named without a submission number | |
| † | K063453 | Vertefix Pedicle Screw Spinal System | 2007 |
| † | K130274 | Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System | 2013 |
| † | K070758 | Stryker Peek Zip Suture Anchor | 2007 |
| † | K063456 | SRT100 Superficial Radiation Therapy System | 2007 |
| † | K200523 | Biolign® Roto-Loc Cervical Plate System | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture… | 2024 | 0 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 28 of the 188 ancestors have a recall of any class.
- Of its descendants, K242296 (Ortho-Design (Pty), Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K120942.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The VersaTapT ' Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap TM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial…
Read the full statement (408 words)
The VersaTapT ' Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap TM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
Elbow: Tennis elbow repair
Knee: Medial and lateral collateral ligament repair.
Wrist: Scapholunate ligament reconstruction
The VersaLatTM Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
Shoulder: Rotator Cuff Repair, Biceps Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis
The DueLockTM Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The DueLockTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Capsular Shift and Capsulolabral Reconstruction, Subscapularis Tendon Tears
Elbow: Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Metatarsal Tendon Repair.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
Hip: Acetabular labral repair.
The VersaTiTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus
Elbow: Tennis elbow repair
Knee: Medial and lateral collateral ligament repair, Joint capsule closure
Wrist: Scapholunate ligament reconstruction
Hip: Capsular Repair, acetabular labral repair
The MiniTi~m Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MiniTiTM Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as:
Elbow: Ulnar/Medial Collateral Ligament Repair
Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212381
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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