510(k) · Cleared
ClearedParcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Jul 28, 2011 as substantially equivalent to K090075 (Parcus Medical, LLC, 2009) and 2 other predicates after a 108-day review. Its family tree reaches back 10 generations to 1991. 4 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K911837 (1991). 65 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 6 generations between
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 1 generation backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- This deviceK111000 Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011
- Descendant · cites it directly · 3 of its ownK201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020
- Descendant · cites it directly · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002)…Ortho-Design (Pty), Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK212739 ActiFlipParcus Medical, LLC · 2021
Show all 10 generations
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 8 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 7 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 6 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 5 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 4 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 1 generation backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- This deviceK111000 Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011
Most influential descendants
Showing 4 of 4 · See all- K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020 · cites it directly3descendants
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · cites it directly1descendant
- K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd. · 2024 · 2 generations on0descendants
- K212739ActiFlipParcus Medical, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −9 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −8 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −7 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −6 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −5 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −4 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −3 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −2 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −1 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| 0 (this device) | 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 | — |
| +1 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +2 | K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™… | Ortho-Design (Pty), Ltd. | 2024 | — |
| +1 | K212739 | ActiFlip | Parcus Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Summary page 1…ener, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: *Parcus V-LoX Titanium Suture Anchors (1(090075) *Smith & Nephew Twinfix Ti 2.8 Suture Anchor (K(053344) *Smith & Nephew MIN ITAC Ti 2.0 Suture Anchor (1(000797) Device Descri… | 2009 |
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: *Parcus V-LoX Titanium Suture Anchors (1(090075) *Smith & Nephew Twinfix Ti 2.8 Suture Anchor (K(053344) *Smith & Nephew MIN ITAC Ti 2.0 Suture Anchor (1(000797) Device Description: The Parcus MiTi Suture Anchor is a threaded, taper… | 2006 |
| * | K000797 | Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01Summary page 1…ate Devices: *Parcus V-LoX Titanium Suture Anchors (1(090075) *Smith & Nephew Twinfix Ti 2.8 Suture Anchor (K(053344) *Smith & Nephew MIN ITAC Ti 2.0 Suture Anchor (1(000797) Device Description: The Parcus MiTi Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone.… | 2000 |
What descends from it? (4)
3 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 20 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 65 ancestors have a recall of any class.
- Of its descendants, K201083 (Parcus Medical, LLC, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K090075.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromnioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular…
Read the full statement (103 words)
The Parcus MiTi Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder Rotator Cuff Repair, Acromnioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
HandWrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111000: Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111000
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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