510(k) · Cleared
ClearedGraftlock Screw, ST Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocomposites, Ltd. · HWC Screw, Fixation, Bone
Cleared on Aug 14, 2007 after a 29-day review. The FDA summary names no predicate by number.
- Decided
- Aug 14, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 GraftLok T M Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLokTM Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLokTM Screw is used to provide interference fixation during femoral…
Read the full statement (122 words)
The GraftLok T M Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.
The GraftLokTM Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The GraftLokTM Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi tendonosis gracilis).
The GraftLokTM ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The GraftLokTM ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071952: Graftlock Screw, ST Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071952
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026