510(k) · Cleared

Cleared

Resorbable Screw Anchor

K012872510(k) TraditionalCleared Nov 20, 200185-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

Arthrotek, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 20, 2001 as substantially equivalent to K943806 (Biomet, Inc., 1995) and 4 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1995. 30 later devices descend from it.

Decided: Nov 20, 2001
Review: 85 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K943806 (1995). 5 ancestors in all. 30 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
This deviceK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
Descendant · cites it directly · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
Descendant · 2 generations on · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
Descendant · cites it directly · 8 of its ownK033355 Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004
Descendant · 3 generations on · 7 of its ownK110230 Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011
Descendant · 2 generations on · 7 of its ownK061801 2.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003high 6 (2011) · low 0 (2005)2026

Most influential descendants

Showing 5 of 30 · See all

K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · cites it directly26descendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · 2 generations on9descendants
K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004 · cites it directly8descendants
K110230Rog Knotless Suture AnchorRog Sports Medicine, Inc. · 2011 · 3 generations on7descendants
K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943806	Harpoon Suture Anchors	Biomet, Inc.	1995	—
0 (this device)	K012872	Resorbable Screw Anchor	Arthrotek, Inc.	2001	—
+1	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+2	K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	1
+1	K033355	Lactoscrew Screw Anchor	Biomet Orthopedics, Inc.	2004	—
+3	K110230	Rog Knotless Suture Anchor	Rog Sports Medicine, Inc.	2011	—
+2	K061801	2.8 & 3.5MM Lactoscrew Suture Anchors	Arthrotek, Inc.	2006	—

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
2003	1	0
2004	3	0
2006	2	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

FIG. 1 — Lineage of K012872, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K943806	Harpoon Suture Anchors Summary page 1 …xation, Biodegradable, Soft Tissue Device Product Code: 87MAI Legally Marketed Devices To Which Substantial Equivalence is Claimed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), LactoSorb® Suture Anchor (Biomet, Inc., K954443), LactoSorb® Screw Anchor (Biomet, Inc., K0O03273), Resorbable Bone Pin…	Biomet, Inc.	1995	—
*	K973775	Harpoon Suture Anchors Summary page 1 …Biodegradable, Soft Tissue Device Product Code: 87MAI Legally Marketed Devices To Which Substantial Equivalence is Claimed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), LactoSorb® Suture Anchor (Biomet, Inc., K954443), LactoSorb® Screw Anchor (Biomet, Inc., K0O03273), Resorbable Bone Pin (Biomet…	Biomet, Inc.	1998	—
*	K954443	Lactosorb Suture Anchor Summary page 1 …MAI Legally Marketed Devices To Which Substantial Equivalence is Claimed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775), LactoSorb® Suture Anchor (Biomet, Inc., K954443), LactoSorb® Screw Anchor (Biomet, Inc., K0O03273), Resorbable Bone Pin (Biomet, Inc., K011522). Indications for Use: Indication…	Poly-Medics,Inc.	1996	—
*	K003273	Lactosorb Screw Anchor	Biomet, Inc.	2001	—
*	K011522	Resorbable Bone Pins Summary page 1 …r (Biomet, Inc., K943806/K973775), LactoSorb® Suture Anchor (Biomet, Inc., K954443), LactoSorb® Screw Anchor (Biomet, Inc., K0O03273), Resorbable Bone Pin (Biomet, Inc., K011522). Indications for Use: Indications for the Resorbable Screw Anchor includes use in soft tissue reattachment procedures in the sh…	Biomet, Inc.	2001	—

Also cleared against K943806: 3 other devices →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	26
K033355	Lactoscrew Screw Anchor	Biomet Orthopedics, Inc.	2004	8
K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	6
K032072	Lactosorb L15 Screw Anchor with Lactocarbonate Suture	Arthrotek, Inc.	2003	0

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?

None of the 5 ancestors has a recall.
Of its descendants, K041274 (Arthrotek, Inc., 2004) has gone furthest, with 26 descendants of its own.
3 other devices also cite its predicate K943806.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

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

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

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 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 tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament…

Read the full statement (105 words)

Indications for the Resorbable 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 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: 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012872 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012872: Resorbable 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/K012872

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026