510(k) · Cleared
ClearedCancellous Fixation Screw & Washer for Use W/Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concept, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 25, 1987 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Mar 25, 1987
- Review
- 8 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- Descendant · cites it directly · 5 of its ownK981967 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 · 2 generations on · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK961649 Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc. · 1996
- Descendant · 3 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Arthrotek/Biomet, Inc. · 1998 · cites it directly5descendants
- 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 · 2 generations on3descendants
- K961649Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc. · 1996 · cites it directly3descendants
- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| +1 | 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 | — |
| +2 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +1 | K961649 | Acufex Tibial Anchor Screw & Spiked Washer | Smith & Nephew Endoscopy, Inc. | 1996 | — |
| +3 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 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?
- Of its descendants, K981967 (Arthrotek/Biomet, Inc., 1998) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K871037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K871037: Cancellous Fixation Screw & Washer for Use W/Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871037
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026