510(k) Report

510(k) · Cleared

Cleared

Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying Diameters,

K091202510(k) TraditionalCleared Sep 16, 2009145-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medshape Solutions · HWC Screw, Fixation, Bone

Cleared on Sep 16, 2009 as substantially equivalent to K083792 (Medshape Solutions, 2009) and 2 other predicates after a 145-day review. Its family tree reaches back 4 generations to 1999. 3 later devices descend from it.

Decided
Sep 16, 2009
Review
145 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K990088 (1999). 12 ancestors in all, the oldest K971723 (1997). 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2001: 2 other ancestors2000: 4 other ancestors1997: 1 other ancestor2009: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant clearedK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K083792 · Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055 · Medshape Solutions · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants K083792 · Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055 · Medshape Solutions · 2009K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990
  1. Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 1 generation backK083792 Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions · 2009
  5. This deviceK091202 Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model…Medshape Solutions · 2009
  6. Descendant · cites it directly · 0 of its ownK141290 Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014
  7. Descendant · cites it directly · 0 of its ownK130467 Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc. · 2013
  8. Descendant · cites it directly · 0 of its ownK092914 Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with…Medshape Solutions · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K141290Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014 · cites it directly0descendants
  • K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc. · 2013 · cites it directly0descendants
  • K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−3K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−2K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−1K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions2009—
0 (this device)K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab…Medshape Solutions2009—
+1K141290Helical Ridge Peek Interference ScrewMedShape, Inc.2014—
+1K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.2013—
+1K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200040
200120
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201410
FIG. 1 — Lineage of K091202, 1999–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055
Summary page 1
…Synthetic, Polyethylene GAT 21 CFR 878.500 E. Predicate Device(s): MSS, WedgeLoc TM Suture Anchor with Opti-FiberT M Suture, K083792 Arthrex PushLockT M Suture Anchor, K051219 Arthrex FiberWIRE T M Polyblend Suture, K021434 F. Labeling and Intende…
Medshape Solutions2009—
*K051219Pushlock
Summary page 1
…GAT 21 CFR 878.500 E. Predicate Device(s): MSS, WedgeLoc TM Suture Anchor with Opti-FiberT M Suture, K083792 Arthrex PushLockT M Suture Anchor, K051219 Arthrex FiberWIRE T M Polyblend Suture, K021434 F. Labeling and Intended Use: NOTE: Draft labels and instructions…
Arthrex, Inc.2005—
*K021434Arthrex Fiberwire in Usp Sizes
Summary page 1
…): MSS, WedgeLoc TM Suture Anchor with Opti-FiberT M Suture, K083792 Arthrex PushLockT M Suture Anchor, K051219 Arthrex FiberWIRE T M Polyblend Suture, K021434 F. Labeling and Intended Use: NOTE: Draft labels and instructions for use can be found in Attachment D. However, n…
Arthrex, Inc.2002—

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140
K130467Porous Morphix Suture Anchor with Force Fiber SutureMedShape, Inc.20130
K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions20090

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 12 ancestors have a recall of any class.
  • Of its descendants, K141290 (MedShape, Inc., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HWC devices

HWC 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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The MedShape Solutions, Inc., WedgeLoc TM 180X Suture Anchor with Opti-FiberT M 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…

Read the full statement (114 words)

The MedShape Solutions, Inc., WedgeLoc TM 180X Suture Anchor with Opti-FiberT M 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, 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.

More from Medshape Solutions

5 FDA decisions under this applicant name. See the company

  • K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX…Medshape Solutions · 2011
  • K101808Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue FastnerMedshape Solutions · 2010
  • K092914Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber SuturesMedshape Solutions · 2009
  • K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions · 2009

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K091202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091202: Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying Diameters,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091202

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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