510(k) · Cleared
ClearedWasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 10, 2020 as substantially equivalent to K981967 (Arthrotek/Biomet, Inc., 1998) and 4 other predicates after a 355-day review. Its family tree reaches back 6 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 10, 2020
- Review
- 355 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K922322 (1992). 41 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
- 5 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
- 4 generations backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
- 3 generations backK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
- 2 generations backK140891 Biomet Cannulated Screw SystemBiomet, Inc. · 2014 · Recalled
- 1 generation backK143188 3.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp · 2014 · Recalled
- This deviceK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
- Descendant · 2 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
- Descendant · 2 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023
Most influential descendants
Showing 3 of 3 · See all- K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly2descendants
- K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 2 generations on0descendants
- K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922322 | Alphatec 3.5MM Znnulated Cortical Lag Screw | Alphatec Mfg., Inc. | 1992 | — |
| −5 | K013534 | Self-Countersinking Bone Screw | Biomet Orthopedics, Inc. | 2001 | — |
| −4 | K024086 | Propeller Head Small Cannulated Screw System | Biomet Orthopedics, Inc. | 2003 | — |
| −3 | K082874 | Biodrive Cannulated Screw System | Biomet Trauma | 2009 | — |
| −2 | K140891 | Biomet Cannulated Screw System | Biomet, Inc. | 2014 | 5 |
| −1 | K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014 | 1 |
| 0 (this device) | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw… | Biomet, Inc. | 2020 | — |
| +1 | K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021 | — |
| +2 | K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024 | — |
| +2 | K230226 | Integrity-SI® Fusion System | OsteoCentric Technologies | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K981967 | Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Summary page 6…(21 Compression and Twist-Off CFR 888.3040) Screws Predicate Device(s): K981967 WasherLocTM, Biomet Sports Medicine Ligament Washer, Lo-Prof… | 1998 |
| * | K122437 | NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersSummary page 6…Washer, Lo-Profile, Heckman, and Channel Ligament Screw Systems K122437 WasherLocTM and No-Profile Screw and Washer Systems… | 2013 |
| * | K140891 | Biomet Cannulated Screw SystemSummary page 6…437 WasherLocTM and No-Profile Screw and Washer Systems K140891 Biomet Cannulated Screw System K143188 3.0mm Biomet Cannulated Screw… | 2014 |
| * | K143188 | 3.Omm Biomet Cannulated Screw SystemSummary page 6…Systems K140891 Biomet Cannulated Screw System K143188 3.0mm Biomet Cannulated Screw System K190035 Headless Compression an… | 2014 |
| * | K190035 | Biomet Headless Compression and Twist-Off ScrewsSummary page 6…et Cannulated Screw System K143188 3.0mm Biomet Cannulated Screw System K190035 Headless Compression and Twist-Off Screws Purpose and Device… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211290 | Cannulated Fasteners and Nuts | 2021 | 2 |
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 28 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K211290 (OsteoCentric Technologies, 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K981967.
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. 2020, this device’s year, is highlighted.
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. Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in: 1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow. 2. Arthrodesis of the foot, wrist and elbow. 3. Small and long bone osteotomies. 4. Fracture fixation of small bones, small bone fragments and long bones. Large Cannulated Screws (5mm and larger in…
Read the full statement (228 words)
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
1. Fixation of fractures in long bones and long bone fragments.
2. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
3. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
1. Slipped capital femoral epiphysis
2. Pediatric femoral neck fractures
3. Tibial plateau fractures
4. SI joint disruptions
5. Intercondylar femur fractures
6. Subtalar arthrodesis
7. Fixation of pelvis and iliosacral joint.
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193214: WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193214
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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