510(k) · Cleared
Recalled · Class II · 2018Resorbable Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 28, 2004 as substantially equivalent to K982497 (Biomet, Inc., 1998) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1995. 26 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 28, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943806 (1995). 10 ancestors in all, the oldest K931519 (1994). 26 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 1 generation backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- This deviceK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK061801 2.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 5 of its ownK111590 Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · cites it directly9descendants
- K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 2 generations on7descendants
- K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006 · cites it directly7descendants
- K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · 2 generations on6descendants
- K111590Rog Suture Anchor, Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 3 generations on5descendants
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) | K041274 | Resorbable Interference Screw | Arthrotek, Inc. | 2004 | — |
| +1 | K070389 | Peek Knotless Anchors | Biomet Sports Medicine, Inc. | 2007 | 1 |
| +2 | K110230 | Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
| +1 | K061801 | 2.8 & 3.5MM Lactoscrew Suture Anchors | Arthrotek, Inc. | 2006 | — |
| +2 | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop Constructs | Biomet Manufacturing, Inc. | 2008 | 8 |
| +3 | K111590 | Rog Suture Anchor, Rog Knotless Suture Anchor | Rog Sports Medicine, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2023 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982497 | Arthrotek Interference ScrewSummary page 2…nce Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Artbrotek interference Screw (K982497). More sizes have been added. Non-Clinical Testing-. Mechanical testing was done on the, 3.0 wim Resorbable. Interference Sc… | 1998 |
| * | K012572 | Soft Tissue Screw and WasherSummary page 1…ivalence Is Claimed: Arthrotek Interference Screw - Arthrotek Inc. (K(982497) Soft Tissue Screw and Washer - Arthrotek Inc. (K(012572) Resorbable Screw Anchor - Arthrotek Inc, ((01 2872) Device Description: The 3 mm, 4 mm, 5 mm, 6 mm, 10… | 2001 |
| * | K012872 | Resorbable Screw Anchor | 2001 |
What descends from it? (26)
See all 266 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2018 | Class II | Z-1737-2018 | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. |
| Mar 28, 2018 | Class II | Z-1738-2018 | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. |
| Mar 28, 2018 | Class II | Z-1736-2018 | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. |
| Mar 28, 2018 | Class II | Z-1735-2018 | Nonconforming Material/Component | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle. |
| Jun 3, 2015 | Class II | Z-1944-2015 | Mixed-up of materials/components | Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K070389 (Biomet Sports Medicine, Inc., 2007) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K982497.
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 Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, snkle/foot, elbow, and knee. Specific indications include the following: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavieular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral…
Read the full statement (186 words)
Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, snkle/foot, elbow, and knee. Specific indications include the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavieular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, 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: Extra-capsular repair, mediac collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquns (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mnm screws are indicated for the following uses:
1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (senitendinosus, gracilis).
3. To provide interference fixation during posterior cmeciate ligament (PCL) reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041274: Resorbable Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041274
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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