510(k) · Cleared
ClearedSyntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Endophix Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 23, 2023 as substantially equivalent to K083635 (Smith & Nephew Endoscopy, Inc., 2009) and 1 other predicate after a 54-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- May 23, 2023
- Review
- 54 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961555 (1996). 23 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.
- 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 backK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- 1 generation backK093943 Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div. · 2010
- This deviceK230874 Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd. · 2023
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 | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| −1 | K093943 | Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM | Smith & Nephew Inc., Endoscopy Div. | 2010 | — |
| 0 (this device) | K230874 | Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath | Suzhou Endophix Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K083635 | Smith & Nephew Biosure PK Interference ScrewSummary page 6…w Common Name: Screw, Fixation, Bone Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K083635 Manufacturer: Smith & Nephew Inc., Endoscopy Division Trade Name: BIOSURE SYNC Tibial Fixation D… | 2009 |
| * | K093943 | Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSummary page 7…1 K230874 Premarket Notification: K093943 Manufacturer: Smith & Nephew Inc., Endoscopy Division IV Device description All Syntheface PEEK Interference S… | 2010 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 23 ancestors have a recall of any class.
- 10 other devices also cite its predicate K083635.
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. 2023, 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 Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures: Knee -ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair…
Read the full statement (180 words)
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to
bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also
indicated for use in the following procedures:
Knee
-ACL Repair
-PCL Repair
-Extra-capsular repair
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
-Patellar realignment and tendon repair
Vastus medialis obliquus advancement
-Iliotibial band tenodesis
Shoulder
-Capsular stabilization
Bankart repair
Anterior shoulder instability
SLAP lesion repair
Capsular shift or capsulolabral reconstruction
-Acromioclavicular separation repair
-Deltoid repair
-Rotator cuff tear repair
-Biceps tenodesis
Foot and Ankle
-Hallux valgus repair
-Medial or lateral instability repair/reconstruction
-Achilles tendon repair/reconstruction
-Midfoot reconstruction
-Metatarsal ligament/tendon repairs/reconstruction
-Bunionectomy
-Flexor Hullucis Longus (FLH)
-Tendon Transfer
Elbow, Wrist, and Hand
-Biceps tendon reattachment
-Ulnar or radial collateral ligament reconstruction
-Lateral epicondylitis repair
-Scapholunate ligament reconstruction
-Tendon Transfer
-Carpometacarpal Joint Arthroplasty
-Carpal Ligament Reconstruction
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for
fixation of soft tissue to bone during cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230874: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230874
Report an extraction error
Are you the manufacturer?
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