510(k) · Cleared
ClearedNonresorbable Centraloc Tibial Screw & Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 29, 2005 as substantially equivalent to K033233 (Biomet, Inc., 2003) and 2 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 29, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K911837 (1991). 16 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 4 generations backK984490 Sutureless AnchorInnovasive Devices, Inc. · 1999
- 3 generations backK012469 Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc. · 2001
- 2 generations backK021832 Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002
- 1 generation backK033233 Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003
- This deviceK051069 Nonresorbable Centraloc Tibial Screw & WasherArthrotek, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −4 | K984490 | Sutureless Anchor | Innovasive Devices, Inc. | 1999 | — |
| −3 | K012469 | Resorbable NO Profile Screw and Washer | Biomet Manufacturing, Inc. | 2001 | — |
| −2 | K021832 | Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer | Biomet, Inc. | 2002 | — |
| −1 | K033233 | Lactosorb Tibial L-15 Screw and Washer | Biomet, Inc. | 2003 | — |
| 0 (this device) | K051069 | Nonresorbable Centraloc Tibial Screw & Washer | Arthrotek, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K033233 | Lactosorb Tibial L-15 Screw and WasherSummary page 1…Is Claimed: Legally Marketed Devices To Which Substantial Equivalence LactoSorb~f' Tibial L- 15 Screw and Washer - Arthrotek Inc. (K033233) Inc. (K02 1832) N~o Profile La… | 2003 |
| * | K021832 | Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherSummary page 1…LactoSorb~f' Tibial L- 15 Screw and Washer - Arthrotek Inc. (K033233) Inc. (K02 1832) N~o Profile LadeoSorb®"L- 15 Screw and \Vasher - Arthrotek STALEF TT - Surgicraft Ltd. (K0… | 2002 |
| * | K041617 | Stalif TTSummary page 1…Inc. (K02 1832) N~o Profile LadeoSorb®"L- 15 Screw and \Vasher - Arthrotek STALEF TT - Surgicraft Ltd. (K04 1617) and Washers are a series of Device Description: The Nonr… | 2004 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K033233.
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?
1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (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/K051069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K051069: Nonresorbable Centraloc Tibial Screw & Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K051069
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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