510(k) · Cleared
ClearedMitek Rapidloc-PDS Meniscal Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Worldwide · JDR Staple, Fixation, Bone
Cleared on Dec 27, 2002 as substantially equivalent to K002406 (Mitek Products, 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 27, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970119 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970119 Mitek Absorbable Polydioxanone (PDS) H FixMitek Products · 1998
- 1 generation backK002406 Mitek 2GII Meniscal Repair SystemMitek Products · 2001
- This deviceK023388 Mitek Rapidloc-PDS Meniscal Repair SystemMitek Worldwide · 2002
- Descendant · cites it directly · 0 of its ownK092836 Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · cites it directly · 0 of its ownK082518 Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970119 | Mitek Absorbable Polydioxanone (PDS) H Fix | Mitek Products | 1998 | — |
| −1 | K002406 | Mitek 2GII Meniscal Repair System | Mitek Products | 2001 | — |
| 0 (this device) | K023388 | Mitek Rapidloc-PDS Meniscal Repair System | Mitek Worldwide | 2002 | — |
| +1 | K092836 | Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +1 | K082518 | Dual Needle Suture Passer System | Cayenne Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K002406 | Mitek 2GII Meniscal Repair SystemSummary page 1…(Class 11,21 CFR 888.3030, Product code: 87 Predicate Device(s): RAPIDLOC Meniscal Repair System (K002406) Mitek ‘‘”-Fix Meniscal Fastener (IC9701 19) Device Description:… | 2001 |
| * | K970119 | Mitek Absorbable Polydioxanone (PDS) H Fix | 1998 |
What descends from it? (2)
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092836 (Depuy Mitek, A Johnson & Johnson Company, 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K002406.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023388: Mitek Rapidloc-PDS Meniscal Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023388
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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