510(k) · Cleared
ClearedLactosorb Tibial L-15 Screw and Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 5, 2003 as substantially equivalent to K021832 (Biomet, Inc., 2002) after a 30-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911837 (1991). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 3 generations backK984490 Sutureless AnchorInnovasive Devices, Inc. · 1999
- 2 generations backK012469 Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc. · 2001
- 1 generation backK021832 Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002
- This deviceK033233 Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
- Descendant · cites it directly · 0 of its ownK051069 Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −3 | K984490 | Sutureless Anchor | Innovasive Devices, Inc. | 1999 | — |
| −2 | K012469 | Resorbable NO Profile Screw and Washer | Biomet Manufacturing, Inc. | 2001 | — |
| −1 | K021832 | Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer | Biomet, Inc. | 2002 | — |
| 0 (this device) | K033233 | Lactosorb Tibial L-15 Screw and Washer | Biomet, Inc. | 2003 | — |
| +1 | K130731 | Stabiliz Fixation System - SPL Locking Screw | Stabiliz Orthopaedics, LLC | 2013 | — |
| +1 | K051069 | Nonresorbable Centraloc Tibial Screw & Washer | Arthrotek, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 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 22.3 · 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 |
|---|---|---|---|
| * | K021832 | Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherSummary page 1…1 CFR 888.3040 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrotek Resorbable No-Profile Lactosorb@ L-I 5 Screw and Washer cleared in 510(k) K021832). Device Description: The device description of the Lactosorb@Tibial L-15 Screw and Washer is as follows: Resorbable screw in… | 2002 |
What descends from it? (2)
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 12 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K130731 (Stabiliz Orthopaedics, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021832.
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?
The LactoSorb Tibial L-15 Screw and Washer is indicated for the following procedures:
1. ACL and PCL reconstruction
2. Medial collateral ligament repair
3. Lateral collateral ligament repair
4. Posterior oblique ligament repair
5. iliotibial band tenodesis reconstruction
6. Patellar ligament and tendon repair
This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033233 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033233: Lactosorb Tibial L-15 Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033233
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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