510(k) · Cleared
ClearedWasherloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System, Channel Ligament Clamp, Heckman Scre
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek/Biomet, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 17, 1998 as substantially equivalent to K871037 (Concept, Inc., 1987) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871037 (1987). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- This deviceK981967 Washerloc Screw System, Ligament Screw System, NO-Profile…Arthrotek/Biomet, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK122437 NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc…Biomet Sports Medicine · 2013
- Descendant · cites it directly · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 3 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 5 of 5 · See all- K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine · 2013 · cites it directly4descendants
- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · cites it directly3descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 3 generations on0descendants
- K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| 0 (this device) | K981967 | Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw… | Arthrotek/Biomet, Inc. | 1998 | — |
| +1 | K122437 | NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc Washers | Biomet Sports Medicine | 2013 | — |
| +1 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +2 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +3 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +3 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 |
|---|---|---|---|
| * | K871037 | Cancellous Fixation Screw & Washer for Use W/ScrewSummary page 1…mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone. . Substantially Equivelent Devices: e Cancellous Fixation Screw & Washer (Concept, Inc.) K871037 (now marketed by Linvatec) MLI Soft Tissue Screw & Washer (Medicine Lodge, Inc.) K962194 (now marketed by Innovasive) SMo Bone… | 1987 |
| * | K962194 | Mli Soft Tissue Screw & Washer SystemSummary page 1…tially Equivelent Devices: e Cancellous Fixation Screw & Washer (Concept, Inc.) K871037 (now marketed by Linvatec) MLI Soft Tissue Screw & Washer (Medicine Lodge, Inc.) K962194 (now marketed by Innovasive) SMo Bone Screws (OEC) Preamendment MATLING ADDRESS SUHIPPING ADDRESS 12O, Box 587 Airport Industria… | 1996 |
| * | — | SMo Bone Screws (OEC) Named without a submission number |
What descends from it? (5)
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?
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
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/K981967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981967: Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System, Channel Ligament Clamp, Heckman Scre.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981967
Report an extraction error
Are you the manufacturer?
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