510(k) Report

510(k) · Cleared

Cleared

Lactosorb L15 Screw Anchor with Lactocarbonate Suture

K032072510(k) TraditionalCleared Oct 1, 200390-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 Oct 1, 2003 as substantially equivalent to K012872 (Arthrotek, Inc., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1995.

Decided
Oct 1, 2003
Review
90 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K943806 (1995). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1997: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestorK943806 · Harpoon Suture Anchors · Biomet, Inc. · 1995K012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 200119961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors K012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K943806 · Harpoon Suture Anchors · Biomet, Inc. · 19950
  1. Root · 2 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
  2. 1 generation backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
  3. This deviceK032072 Lactosorb L15 Screw Anchor with Lactocarbonate SutureArthrotek, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K943806Harpoon Suture AnchorsBiomet, Inc.1995—
−1K012872Resorbable Screw AnchorArthrotek, Inc.2001—
0 (this device)K032072Lactosorb L15 Screw Anchor with Lactocarbonate SutureArthrotek, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200120
FIG. 1 — Lineage of K032072, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012872Resorbable Screw Anchor
Summary page 1
…me: Fastener, Fixation, Biodegradable Soft tissue; 87 MA1 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biomet's Lactosorb@L15 Screw Anchor (K012872), Ethicon's Mitek Panalok Suture Anchor System (K970;396),and Biomet's Lactosorb@L18 Screw Anchor (K003273). Device Descri tion:…
Arthrotek, Inc.2001—
*K970896Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System
Our reading of the summary gave K970396, FDA’s number for Human Chorionic Gonadotropin Calibrator (Dade Chemistry Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Mitek Panalok Suture Anchor System”.
ETHICON, Inc.1997—
*K003273Lactosorb Screw Anchor
Summary page 1
…l Equivalence Is Claimed: Biomet's Lactosorb@L15 Screw Anchor (K012872), Ethicon's Mitek Panalok Suture Anchor System (K970;396),and Biomet's Lactosorb@L18 Screw Anchor (K003273). Device Descri tion: B The L,xtoSorb Screw Anchor's are resorbable suture anchors used to reattach soft tissue t…
Biomet, Inc.2001—

Also cleared against K012872: 3 other devices →

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.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
  • None of the 7 ancestors has a recall.
  • 3 other devices also cite its predicate K012872.

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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
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

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

Indications for the Lactosorb Screw Anchor with Lactocarbonate Suture includes the 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…

Read the full statement (108 words)

Indications for the Lactosorb Screw Anchor with Lactocarbonate Suture includes the 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 repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Indications for use as stated in the FDA summary.

Also cleared against K012872

3 other devices cite the same predicate.

  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls
  • K041274Resorbable Interference ScrewArthrotek, Inc. · 20045 recalls
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

More from Arthrotek, Inc.

17 FDA decisions under this applicant name. See the company

  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  • K0618012.8 & 3.5MM Lactoscrew Suture AnchorsArthrotek, Inc. · 2006
  • K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K061389Allthread Lactosorb Suture AnchorArthrotek, Inc. · 2006
  • K060693Microstrike and Allthread Peek Suture AnchorArthrotek, Inc. · 2006

Recent decisions in HWC

The HWC category page

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  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K032072 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032072: Lactosorb L15 Screw Anchor with Lactocarbonate Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032072

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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