510(k) · Cleared
ClearedShapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue Fastner
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 Nov 8, 2010 as substantially equivalent to K062466 (Arthrex, Inc., 2006) after a 132-day review. Its family tree reaches back 2 generations to 2005. 4 later devices descend from it.
- Decided
- Nov 8, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052607 (2005). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK052607 Arthrex Interference Screw-Rounded Head Screws, Full Threaded…Arthrex, Inc. · 2005
- 1 generation backK062466 Arthrex Interference ScrewArthrex, Inc. · 2006
- This deviceK101808 Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST…Medshape Solutions · 2010
- Descendant · cites it directly · 2 of its ownK123350 Eclipse Soft Tissue FastenerMedShape, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK141290 Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK132783 Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K123350Eclipse Soft Tissue FastenerMedShape, Inc. · 2013 · cites it directly2descendants
- K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 2011 · cites it directly1descendant
- K141290Helical Ridge Peek Interference ScrewMedShape, Inc. · 2014 · 2 generations on0descendants
- K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed… | Arthrex, Inc. | 2005 | — |
| −1 | K062466 | Arthrex Interference Screw | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K101808 | Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis)… | Medshape Solutions | 2010 | — |
| +1 | K123350 | Eclipse Soft Tissue Fastener | MedShape, Inc. | 2013 | — |
| +1 | K111471 | Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) | Medshape Solutions, Inc. | 2011 | 1 |
| +2 | K141290 | Helical Ridge Peek Interference Screw | MedShape, Inc. | 2014 | — |
| +1 | K132783 | Exoshape Duo Soft Tissue Fastener | MedShape, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K062466 | Arthrex Interference ScrewSummary page 2…The ShapeLoc TM Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate device: Arthrex Interference Screw, K062466 Both fasteners are comprised of implant grade PEEK. Both fasteners have the same indications for use. In addition, fu… | 2006 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123350 (MedShape, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K062466.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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., ShapeLaC TM Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures: Shoulder: Rotator Cuff Repairs, 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…
Read the full statement (137 words)
The MedShape Solutions, Inc., ShapeLaC TM Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, 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, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, 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, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101808: Shapeloc-CL (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-ST (Tenodesis) Soft Tissue Fastner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101808
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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