510(k) · Cleared
ClearedSuper Staple (TM) Classic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metric Medical Devices, Inc. · JDR Staple, Fixation, Bone
Cleared on Jan 3, 2013 after a 63-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Jan 3, 2013
- Review
- 63 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK123363 Super Staple (TM) ClassicMetric Medical Devices, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK162354 Sniper Staple SystemTrilliant Surgical, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK223056 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK230550 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK172405 Sniper Staple System, Non-SterileTrilliant Surgical · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K162354Sniper Staple SystemTrilliant Surgical, Ltd. · 2017 · cites it directly5descendants
- K170923JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · cites it directly3descendants
- K223056JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · 2 generations on2descendants
- K230550JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · 3 generations on1descendant
- K172405Sniper Staple System, Non-SterileTrilliant Surgical · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123363 | Super Staple (TM) Classic | Metric Medical Devices, Inc. | 2013 | — |
| +1 | K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017 | — |
| +1 | K170923 | JAWS (TM) Nitinol Staple System | Paragon 28 | 2017 | 1 |
| +2 | K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +3 | K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +2 | K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2023 | 3 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Memory Staple (Depuy) Named without a submission number | |
| * | — | Memory Staple (BioPro, Inc.) Named without a submission number | |
| * | — | EasyClip (Memometal Inc.) Named without a submission number | |
| * | — | OSStaple (BioMedical Enterprises, Inc.) Named without a submission number |
What descends from it? (11)
See all 113 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?
- Of its descendants, K162354 (Trilliant Surgical, Ltd., 2017) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Super Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123363: Super Staple (TM) Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123363
Report an extraction error
Are you the manufacturer?
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