510(k) · Cleared
ClearedMedline UNITE® REFLEX® Hybrid Nitinol Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · JDR Staple, Fixation, Bone
Cleared on Apr 11, 2025 as substantially equivalent to K231885 (Medline Industries, LP, 2023) and 3 other predicates after a 114-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Apr 11, 2025
- Review
- 114 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K954385 (1996). 66 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- 1 generation backK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
- This deviceK243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
Show all 12 generations
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 10 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 9 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 8 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 7 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 6 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 5 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 4 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- 1 generation backK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
- This deviceK243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −11 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −10 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −9 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −8 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −7 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −6 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −4 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −3 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −2 | K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 | — |
| −1 | K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | 2024 | — |
| 0 (this device) | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K231885 | Medline UNITE® REFLEX® Nitinol Staple SystemSummary page 5…n Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Primary Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K231885 K243888 Page 2 of… | 2023 |
| * | K234031 | Medline UNITE Ancillary Foot Recon Plating SystemSummary page 6…Medline Industries, LP Three Lakes Drive Northfield, IL 60093 Predicate Devices Medline UNITE® Ancillary Foot Recon Plating System K234031 Medline UNITE® MIS Foot Recon Screw System K241359 Medline UNITE® REFLEX® Dynamic Discs K211612 Device Description The Medline… | 2024 |
| * | K241359 | Medline UNITE® MIS Foot Recon Screw SystemSummary page 6…Drive Northfield, IL 60093 Predicate Devices Medline UNITE® Ancillary Foot Recon Plating System K234031 Medline UNITE® MIS Foot Recon Screw System K241359 Medline UNITE® REFLEX® Dynamic Discs K211612 Device Description The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufact… | 2024 |
| * | K211612 | Medline UNITE REFLEX Dynamic DiscsSummary page 6…Predicate Devices Medline UNITE® Ancillary Foot Recon Plating System K234031 Medline UNITE® MIS Foot Recon Screw System K241359 Medline UNITE® REFLEX® Dynamic Discs K211612 Device Description The Medline UNITE® REFLEX® Hybrid Nitinol Implants are manufactured from nickel titanium alloy (nitinol). The… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 66 ancestors have a recall of any class.
- 2 other devices also cite its predicate K231885.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis, Scarf and Chevron osteotomies. Implants are intended for single use only.…
Read the full statement (106 words)
The Medline UNITE® REFLEX® Hybrid Nitinol Implants are intended to provide fixation for
fractures, fusions or osteotomies of the bones of short (tarsals) and long (metatarsals, phalanges,
distal tibia and fibula) bones comprising the foot and ankle such as: First metatarsalcuneiform
arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, Lis-Franc arthrodesis,
Scarf and Chevron osteotomies. Implants are intended for single use only.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the
Medline UNITE® REFLEX® Hybrid Nitinol Implant. The Non-Locking Cortical Screws are also
indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture
fixation, appropriate for the size of the device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243888: Medline UNITE® REFLEX® Hybrid Nitinol Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243888
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