510(k) · Cleared
ClearedParcus Ppek CF Interference Screw
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 Sep 30, 2009 as substantially equivalent to K083619 (Parcus Medical, LLC, 2009) and 1 other predicate after a 167-day review. Its family tree reaches back 6 generations to 1996. 4 later devices descend from it.
- Decided
- Sep 30, 2009
- Review
- 167 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K961555 (1996). 23 ancestors in all, the oldest K895711 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 1 generation backK083226 Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
- Descendant · cites it directly · 1 of its ownK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
- Descendant · cites it directly · 1 of its ownK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK200428 Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK132783 Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K170877Parcus SLiK Fix ScrewParcus Medical · 2017 · cites it directly1descendant
- K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 2011 · cites it directly1descendant
- K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on0descendants
- K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −1 | K083226 | Smith & Nephew Peek Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K091093 | Parcus Ppek CF Interference Screw | Parcus Medical, LLC | 2009 | — |
| +1 | K170877 | Parcus SLiK Fix Screw | Parcus Medical | 2017 | — |
| +1 | K111471 | Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) | Medshape Solutions, Inc. | 2011 | 1 |
| +2 | K200428 | Multi-Drive Interference Screw System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K132783 | Exoshape Duo Soft Tissue Fastener | MedShape, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Summary page 1…er, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: * Parcus Titanium Interference Screws (K08361 9) * Smith & Nephew PEEK Interference Screws (K083226) Device Description: The Parcus PEEK CF Interference Screw is a cannulated… | 2009 |
| * | K083226 | Smith & Nephew Peek Interference ScrewSummary page 1…21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: * Parcus Titanium Interference Screws (K08361 9) * Smith & Nephew PEEK Interference Screws (K083226) Device Description: The Parcus PEEK CF Interference Screw is a cannulated, threaded, tapered fastener for use in interference f… | 2009 |
What descends from it? (4)
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 13 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K170877 (Parcus Medical, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K083619.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091093 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091093: Parcus Ppek CF Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091093
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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