# K241164: IB3D™ PL Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International S.A.S. (Medtronic)
- Decided: Sep 6, 2024 after 133 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 550 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 552 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 5.
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek (2020) Summary page 5.
- K163595: IMPIX 3D Print Cages, Medicrea International SA (2017) Summary page 5.

## Most influential descendants
- K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (2025), 0 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-1038-2026: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Oct 29, 2025 · Class II · Z-1039-2026: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

## Indications for use
IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

Source page: https://510kreport.com/device/K241164
Methodology: https://510kreport.com/methodology