510(k) · Cleared
ClearedWedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medshape Solutions · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 9, 2009 as substantially equivalent to K091202 (Medshape Solutions, 2009) and 1 other predicate after a 78-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Dec 9, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990088 (1999). 15 ancestors in all, the oldest K971723 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 4 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 3 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 2 generations backK083792 Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions · 2009
- 1 generation backK091202 Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model…Medshape Solutions · 2009
- This deviceK092914 Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with…Medshape Solutions · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −4 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −3 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −2 | K083792 | Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055 | Medshape Solutions | 2009 | — |
| −1 | K091202 | Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab… | Medshape Solutions | 2009 | — |
| 0 (this device) | K092914 | Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber Sutures | Medshape Solutions | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K091202 | Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Summary page 1…, Soft Tissue HWC/MBI 21 CFR 888.3040 E. Predicate Device(s): MSS, WedgeLoc Tm 180x Suture Anchor with Opti-Fiber T mSuture, K091202 Arthrex PushLock~m 2.5mm Suture Anchor, K063479 F. Labeling and Intended Use: No changes to the labeling or Instru… | 2009 |
| * | K063479 | Arthrex PushlockSummary page 1…BI 21 CFR 888.3040 E. Predicate Device(s): MSS, WedgeLoc Tm 180x Suture Anchor with Opti-Fiber T mSuture, K091202 Arthrex PushLock~m 2.5mm Suture Anchor, K063479 F. Labeling and Intended Use: No changes to the labeling or Instructions for~Use have been made to the submitted i… | 2006 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K091202.
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. 2009, 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 MedShape Solutions, Inc., WedgetocTm 2.5mm Suture Anchor with Opti-FiberTM Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization…
Read the full statement (112 words)
The MedShape Solutions, Inc., WedgetocTm 2.5mm Suture Anchor with Opti-FiberTM Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ul~nar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092914: Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092914
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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