510(k) · Cleared
ClearedSurgicraft Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 13, 2008 as substantially equivalent to K043185 (Synthes (Usa), 2005) and 3 other predicates after a 115-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jun 13, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K990987 (2000). 11 ancestors in all, the oldest K931519 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
- 3 generations backK043337 Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc. · 2004
- 2 generations backK061665 Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc. · 2006
- 1 generation backK071157 Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy · 2007 · Recalled
- This deviceK080447 Surgicraft Screw Fixation SystemSurgicraft, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990987 | Bio-Absorbable Corkscrew, Model AR-1920B | Arthrex, Inc. | 2000 | — |
| −3 | K043337 | Arthrex Bio-Corkscrew FT Suture Anchor | Arthrex, Inc. | 2004 | — |
| −2 | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT | Arthrex, Inc. | 2006 | — |
| −1 | K071157 | Stryker Peek and Titanium Soft Eyelet Anchors | Stryker Endoscopy | 2007 | 5 |
| 0 (this device) | K080447 | Surgicraft Screw Fixation System | Surgicraft, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K043185 | Synthes 3.5MM Cortex ScrewsSummary page 1…d to the predicate devices cleared under the following submissions: * K043185 - Stryker 3.5mm Cortex Screws * K071157 - Stryker Titanium Intraline Anchor… | 2005 |
| * | K071157 | Stryker Peek and Titanium Soft Eyelet AnchorsSummary page 1…the following submissions: * K043185 - Stryker 3.5mm Cortex Screws * K071157 - Stryker Titanium Intraline Anchor * K973775 - Biomet Harpoon Suture Anchors… | 2007 |
| * | K973775 | Harpoon Suture AnchorsSummary page 1…r 3.5mm Cortex Screws * K071157 - Stryker Titanium Intraline Anchor * K973775 - Biomet Harpoon Suture Anchors * K012572 -Biomet Soft Tissue Screws and Washer… | 1998 |
| * | K012572 | Soft Tissue Screw and WasherSummary page 1…Titanium Intraline Anchor * K973775 - Biomet Harpoon Suture Anchors * K012572 -Biomet Soft Tissue Screws and Washers Surgicraft Limited i 16 The Oaks / Clews Road I Redditch i Worc… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 19 other devices also cite its predicate K043185.
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. 2008, 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 Surgicraft Screw Fixation System is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: * Rotator Cuff Repair * Bankart Repair * SLAP Lesion Repair * Acromio-Clavicular Separation Repair * Capsular Shift/Capsulolabral Reconstruction * Biceps Tenodesis * Deltoid Repair. Elbow, Wrist, Hand: * Scapholunate Ligament Reconstruction…
Read the full statement (134 words)
The Surgicraft Screw Fixation System is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
* Rotator Cuff Repair
* Bankart Repair
* SLAP Lesion Repair
* Acromio-Clavicular Separation Repair
* Capsular Shift/Capsulolabral Reconstruction
* Biceps Tenodesis
* Deltoid Repair.
Elbow, Wrist, Hand:
* Scapholunate Ligament Reconstruction
* Ulnar Collateral Ligament Reconstruction
* Radial Collateral Ligament Reconstruction
* Biceps Tendon Reattachment.
Foot and Ankle:
* Medial Instability Repair/Reconstruction
* Lateral Instability Repair/Reconstruction
* Achilles Tendon Repair/Reconstruction
* Midfoot Reconstruction
* Hallux Valgus Reconstruction.
Knee:
* Extra Capsular Repairs
* Medial Collateral Ligament
* Lateral Collateral Ligament
* Posterior Oblique Ligament
* Illiotibial Band Tenodesis
* Patellar Tendon Repair.
Pelvis:
* Bladder Neck Suspension Procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080447 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080447: Surgicraft Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080447
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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