510(k) · Cleared
ClearedWedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medshape Solutions · HWC Screw, Fixation, Bone
Cleared on Mar 25, 2009 as substantially equivalent to K051219 (Arthrex, Inc., 2005) and 1 other predicate after a 96-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990088 (1999). 11 ancestors in all, the oldest K971723 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 2 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 1 generation backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- This deviceK083792 Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions · 2009
- Descendant · cites it directly · 3 of its ownK091202 Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model…Medshape Solutions · 2009
- Descendant · 2 generations on · 0 of its ownK141290 Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK130467 Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK092914 Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with…Medshape Solutions · 2009
Most influential descendants
Showing 4 of 4 · See all- K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions · 2009 · cites it directly3descendants
- K141290Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014 · 2 generations on0descendants
- K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc. · 2013 · 2 generations on0descendants
- K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −2 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −1 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K141290 | Helical Ridge Peek Interference Screw | MedShape, Inc. | 2014 | — |
| +2 | K130467 | Porous Morphix Suture Anchor with Force Fiber Suture | MedShape, Inc. | 2013 | — |
| +2 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K051219 | PushlockSummary page 1…on-degradable, Soft Tissue HWC/MBI and GAT 21 CFR 888.3040 F. Predicate Device(s): Arthrex PushLock TM suture anchor, K051219 Arthrex FiberWIRET M polyblend suture, K021434 1575 Northside Drive, Suite 440, Atlanta, GA 30318… | 2005 |
| * | K021434 | Arthrex Fiberwire in Usp SizesSummary page 1…HWC/MBI and GAT 21 CFR 888.3040 F. Predicate Device(s): Arthrex PushLock TM suture anchor, K051219 Arthrex FiberWIRET M polyblend suture, K021434 1575 Northside Drive, Suite 440, Atlanta, GA 30318 404-249-9156 phone 404-249-9158 fax… | 2002 |
| † | K041894 | Orthofiber | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091202 | Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying… | 2009 | 3 |
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 2.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K091202 (Medshape Solutions, 2009) has gone furthest, with 3 descendants of its own.
- 13 other devices also cite its predicate K051219.
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 MedShape Solutions, Inc., WedgeLoc T M Suture Anchor with Opti-FiberM Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis 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…
Read the full statement (114 words)
The MedShape Solutions, Inc., WedgeLoc T M Suture Anchor with Opti-FiberM Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis 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, Ulnar 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/K083792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083792: Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083792
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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