510(k) · Cleared
ClearedMitek PDS/Pga Staple
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 20, 2002 as substantially equivalent to K946271 (ETHICON, Inc., 1995) after a 190-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Dec 20, 2002
- Review
- 190 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K946271 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K073281Cais StapleDepuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable… | ETHICON, Inc. | 1995 | 1 |
| 0 (this device) | K021953 | Mitek PDS/Pga Staple | Mitek Worldwide | 2002 | — |
| +1 | K073281 | Cais Staple | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946271 | Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed…Summary page 1…(21 CFR 888.3030); Class II Product Code: 87 MA1 Common Name: Biodegradable Fastener, Soft Tissue Fixation Predicate Device(s): K946271 6-0 Coated VICRYL (polyglactin 910) Absorbable Suture PMA N18331 PDS II Suture K97011C Mitek "H" Fix Meni… | 1995 |
| Kept off the family tree | P18331 | PDS II Suture Number could not be read Summary page 1…e: Biodegradable Fastener, Soft Tissue Fixation Predicate Device(s): K946271 6-0 Coated VICRYL (polyglactin 910) Absorbable Suture PMA N18331 PDS II Suture K97011C Mitek "H" Fix Meniscal Fastener DEVICE DESCRIPTION: Product Description The Mitek PDS/PGA Sta… | |
| Kept off the family tree | K970110 | FDA’s K970110 is Bard Flexible Endoscopy Injection System (651019) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073281 | Cais Staple | 2008 | 0 |
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?
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 Mitek PDS/PGA Staple is an absorbable implant used in the fixation of scaffolding (for example periosteal autograft, collagen membranes or synthetic scaffolding) to articular cartilage lesions of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021953: Mitek PDS/Pga Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021953
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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