510(k) · Cleared
ClearedParcus SLiK Fix Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 2, 2017 as substantially equivalent to K091093 (Parcus Medical, LLC, 2009) and 2 other predicates after a 70-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Jun 2, 2017
- Review
- 70 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K961555 (1996). 26 ancestors in all, the oldest K895711 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 2 generations backK083226 Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- 1 generation backK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
- This deviceK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
- Descendant · cites it directly · 0 of its ownK200428 Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −3 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −2 | K083226 | Smith & Nephew Peek Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| −1 | K091093 | Parcus Ppek CF Interference Screw | Parcus Medical, LLC | 2009 | — |
| 0 (this device) | K170877 | Parcus SLiK Fix Screw | Parcus Medical | 2017 | — |
| +1 | K200428 | Multi-Drive Interference Screw System | Nvision Biomedical Technologies, Inc. | 2020 | — |
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 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K091093 | Parcus Ppek CF Interference ScrewSummary page 4…Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code MBI Predicate Device: The predicate devices are the Parcus PEEK CF Interference Screws (K091093, cleared 9/30/09), the Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors (K113730, cleared 1/17/12) and the Parcus Twist PEEK… | 2009 |
| * | K113730 | Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in…Summary page 4…Predicate Device: The predicate devices are the Parcus PEEK CF Interference Screws (K091093, cleared 9/30/09), the Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors (K113730, cleared 1/17/12) and the Parcus Twist PEEK Suture Anchors (K120942, cleared 4/20/1 2). Device Description: Intended Use: The… | 2012 |
| * | K120942 | Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus…Summary page 4…rference Screws (K091093, cleared 9/30/09), the Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors (K113730, cleared 1/17/12) and the Parcus Twist PEEK Suture Anchors (K120942, cleared 4/20/1 2). Device Description: Intended Use: The Parcus SLiK Fix Screws are intended for use in soft tissue to bone r… | 2012 |
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 |
|---|---|---|---|
| K200428 | Multi-Drive Interference Screw System | 2020 | 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 21 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K200428 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091093.
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. 2017, 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 Parcus SLiK Fix Screw is intended for use in soft tissue to bone reattachment procedures. Specific indications are the following: 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…
Read the full statement (102 words)
The Parcus SLiK Fix Screw is intended for use in soft tissue to bone reattachment procedures. Specific indications are the following:
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170877: Parcus SLiK Fix Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170877
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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