510(k) · Cleared
ClearedParcus 3.5MM Peek CF Push-in 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 Nov 15, 2010 as substantially equivalent to K091094 (Parcus Medical, LLC, 2009) and 2 other predicates after a 90-day review. Its family tree reaches back 11 generations to 1991. 5 later devices descend from it.
- Decided
- Nov 15, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911837 (1991). 69 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations between
- 3 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 2 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 1 generation backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- This deviceK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
- Descendant · cites it directly · 2 of its ownK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK122805 Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK222564 Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK213109 Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited · 2022
- Descendant · 2 generations on · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Show all 11 generations
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 10 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 9 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 8 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 7 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 6 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 5 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 4 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 3 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 2 generations backK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
- 1 generation backK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
- This deviceK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · cites it directly2descendants
- K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC · 2013 · cites it directly1descendant
- K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc. · 2022 · 2 generations on0descendants
- K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited · 2022 · 2 generations on0descendants
- K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −10 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −9 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −8 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −7 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −6 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −5 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −4 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −3 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −2 | K090075 | Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 | Parcus Medical, LLC | 2009 | — |
| −1 | K091094 | Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264 | Parcus Medical, LLC | 2009 | — |
| 0 (this device) | K102326 | Parcus 3.5MM Peek CF Push-in Suture Anchor | Parcus Medical, LLC | 2010 | — |
| +1 | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | 2 |
| +1 | K122805 | Parcus Draw Tight 1.8MM Single-Loaded Suture Anchor | Parcus Medical, LLC | 2013 | — |
| +2 | K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | 2022 | — |
| +2 | K213109 | Auxilock Draw Tight Suture-Based Anchor | Auxein Medical Private Limited | 2022 | — |
| +2 | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
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 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K091094 | Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Summary page 1…ener, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: • Parcus V-LoX PEEK CF Suture Anchor (K091094) * Smith & Nephew BioRaptor 2.9 (K031 685, K053344) Device Description: The Parcus 3.5mm PEEK CF Push-In Suture Anchors are tap… | 2009 |
| * | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318Summary page 1…21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: • Parcus V-LoX PEEK CF Suture Anchor (K091094) * Smith & Nephew BioRaptor 2.9 (K031 685, K053344) Device Description: The Parcus 3.5mm PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachm… | 2003 |
| * | 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 PEEK CF Suture Anchor (K091094) * Smith & Nephew BioRaptor 2.9 (K031 685, K053344) Device Description: The Parcus 3.5mm PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachment of so… | 2006 |
What descends from it? (5)
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 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 69 ancestors have a recall of any class.
- Of its descendants, K132912 (In2bones Sas, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K091094.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 3.5mm PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair. Acromioclavicular 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…
Read the full statement (106 words)
The Parcus 3.5mm PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder Rotator Cuff Repair. Acromioclavicular 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.
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102326: Parcus 3.5MM Peek CF Push-in Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102326
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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