510(k) · Cleared
ClearedReverto 55 and 37 Shape Memory Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core Essence Orthopaedics, LLC · JDR Staple, Fixation, Bone
Cleared on Aug 15, 2007 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) and 4 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Aug 15, 2007
- Review
- 78 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K902307 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 1 generation backK051408 Intelifuse, Inc. Warm System with StimulinksIntelifuse, Inc. · 2005
- This deviceK071477 Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
- Descendant · cites it directly · 0 of its ownK141550 Instafix Shape Memory Fixation SystemOt Medical · 2014
Most influential descendants
Showing 1 of 1 · See all- K141550Instafix Shape Memory Fixation SystemOt Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −2 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −1 | K051408 | Intelifuse, Inc. Warm System with Stimulinks | Intelifuse, Inc. | 2005 | — |
| 0 (this device) | K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K993714 | Memograph Staple, Warm SystemSummary page 2…Staples is based on the equivalence in intended use, materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K993714 Biomedical Enterprises Memograph K00t354 Biomedical Enterprises OSStaple K051408 Intelifuse… | 2000 |
| * | K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the… | 2001 |
| * | K051408 | Intelifuse, Inc. Warm System with StimulinksSummary page 2…o: DEVICE Manufacturer Trade Name K993714 Biomedical Enterprises Memograph K00t354 Biomedical Enterprises OSStaple K051408 Intelifuse Stimulink K060014 Intelifuse Stimulink K002695 Telos Medical… | 2005 |
| * | K060014 | Intelifuse, Inc., Warmsystem with StimulinksSummary page 2…Trade Name K993714 Biomedical Enterprises Memograph K00t354 Biomedical Enterprises OSStaple K051408 Intelifuse Stimulink K060014 Intelifuse Stimulink K002695 Telos Medical Memodyn Staples END OF 510(K) SUMMARY… | 2006 |
| * | K002695 | Memodyn StapleSummary page 2…Memograph K00t354 Biomedical Enterprises OSStaple K051408 Intelifuse Stimulink K060014 Intelifuse Stimulink K002695 Telos Medical Memodyn Staples END OF 510(K) SUMMARY Core Essence Orthopaedics, LLC… | 2001 |
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 |
|---|---|---|---|
| K141550 | Instafix Shape Memory Fixation System | 2014 | 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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K141550 (Ot Medical, 2014) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K993714.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
re VERTO TM Shape Memory Staples are 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
reVERTO TM Shape Memory Staples are 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/K071477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071477: Reverto 55 and 37 Shape Memory Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071477
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