510(k) · Cleared
Recalled · Class II · 2020Orthopediatrics Acl Reconstructive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 20, 2013 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 142-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 20, 2013
- Review
- 142 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922559 (1992). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 1 generation backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- This deviceK130217 Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. · 2013
- Descendant · cites it directly · 3 of its ownK212197 WasherCap Fixation SystemAbanza Tecnomed S.L · 2022
- Descendant · 2 generations on · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · 3 generations on · 0 of its ownK253618 QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026
- Descendant · 2 generations on · 0 of its ownK250238 WasherCap™ Fixation SystemAbanza Tecnomed S.L · 2025
Most influential descendants
Showing 4 of 4 · See all- K212197WasherCap Fixation SystemAbanza Tecnomed S.L · 2022 · cites it directly3descendants
- K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · 2 generations on1descendant
- K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026 · 3 generations on0descendants
- K250238WasherCap™ Fixation SystemAbanza Tecnomed S.L · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922559 | Acufex Endofix Button | Acufex Microsurgical, Inc. | 1992 | — |
| −1 | K980155 | Endobutton Continuous Loop | Smith & Nephew, Inc. | 1998 | — |
| 0 (this device) | K130217 | Orthopediatrics Acl Reconstructive System | OrthoPediatrics Corp. | 2013 | — |
| +1 | K212197 | WasherCap Fixation System | Abanza Tecnomed S.L | 2022 | — |
| +2 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +3 | K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026 | — |
| +2 | K250238 | WasherCap™ Fixation System | Abanza Tecnomed S.L | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 1…ion procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. - Titanium Alloy per ASTM F136 PEEK Optima per ASTM F2026 EndoButton CL Ultra (Smith & Nephew, K980155) for the loop fixation implant. . Arthrex Sheathed Cannulated interference Screw (Arthrex, K062466) for the screw & sleeve constr… | 1998 |
| * | K062466 | Arthrex Interference ScrewSummary page 1…F136 PEEK Optima per ASTM F2026 EndoButton CL Ultra (Smith & Nephew, K980155) for the loop fixation implant. . Arthrex Sheathed Cannulated interference Screw (Arthrex, K062466) for the screw & sleeve construct. The fundamental scientific principles and technological characteristics, including the intend… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212197 | WasherCap Fixation System | 2022 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2020 | Class II | Z-2538-2020 | Under Investigation by firm | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to… |
| Jul 25, 2014 | Class II | Z-2560-2014 | Nonconforming Material/Component | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. |
| Nov 7, 2013 | Class II | Z-0579-2014 | Labeling design | Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K212197 (Abanza Tecnomed S.L, 2022) has gone furthest, with 3 descendants of its own.
- 13 other devices also cite its predicate K980155.
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. 2013, 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?
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
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/K130217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130217: Orthopediatrics Acl Reconstructive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130217
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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