510(k) · Cleared
ClearedLactoscrew Screw Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 30, 2004 as substantially equivalent to K012872 (Arthrotek, Inc., 2001) after a 254-day review. Its family tree reaches back 2 generations to 1995. 8 later devices descend from it.
- Decided
- Jun 30, 2004
- Review
- 254 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943806 (1995). 6 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 1 generation backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- This deviceK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK061389 Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
- Descendant · 2 generations on · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006 · cites it directly7descendants
- K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
- K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants
- K193402ALLthread PEEK Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
- K192942ALLthread Titanium Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −1 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| 0 (this device) | K033355 | Lactoscrew Screw Anchor | Biomet Orthopedics, Inc. | 2004 | — |
| +1 | K061389 | Allthread Lactosorb Suture Anchor | Arthrotek, Inc. | 2006 | — |
| +1 | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing, Inc. | 2008 | 8 |
| +2 | K110473 | Nanotack Suture Anchor 1.4MM | Pivot Medical | 2011 | — |
| +2 | K193402 | ALLthread PEEK Suture Anchor | Biomet, Inc. | 2020 | — |
| +2 | K192942 | ALLthread Titanium Suture Anchor | Biomet, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K012872 | Resorbable Screw AnchorSummary page 1…ed metallic bone fixation fastener (21 CFR 888.3040) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable Screw Anchor, K012872 Device Description: This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The… | 2001 |
What descends from it? (8)
2 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 9 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061389 (Arthrotek, Inc., 2006) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K012872.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indications for the LactoScrew TM Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament…
Read the full statement (106 words)
Indications for the LactoScrew TM Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033355: Lactoscrew Screw Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033355
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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