510(k) · Cleared
ClearedInstafix Shape Memory Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ot Medical · JDR Staple, Fixation, Bone
Cleared on Jul 11, 2014 as substantially equivalent to K071477 (Core Essence Orthopaedics, LLC, 2007) after a 30-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jul 11, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902307 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK051408 Intelifuse, Inc. Warm System with StimulinksIntelifuse, Inc. · 2005
- 1 generation backK071477 Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
- This deviceK141550 Instafix Shape Memory Fixation SystemOt Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K051408 | Intelifuse, Inc. Warm System with Stimulinks | Intelifuse, Inc. | 2005 | — |
| −1 | K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | 2007 | — |
| 0 (this device) | K141550 | Instafix Shape Memory Fixation System | Ot Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K071477 | Reverto 55 and 37 Shape Memory StaplesSummary page 1…allic bone fixation Name appliances and accessories Section Orthopedic Product Code JDR Predicate Device reVERTOTM Shape Memory Staples (K07 1477) Device InstaFixTM Shape Memory Fixation System is a set of dynamic Description compression implants made from… | 2007 |
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 24 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
InstaFiXTM Shape Memory Fixation System is intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
InstaFiXTM Shape Memory Fixation System is also indicated for adjunctive fixation of
Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus. Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141550: Instafix Shape Memory Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141550
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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