# K260340: HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC Biologics Osteopoint Lumbar Peek Cages

- Pathway: 510(k) (Traditional)
- Applicant: HC Biologics, LLC
- Decided: Apr 13, 2026 after 70 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K841189 (1984). 542 ancestors in all.
No later device cites it as a predicate yet.
1 of 543 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252781: MSFX Mikron Peek Cages, Mikron Makina Sanayi VE Tic. Ltd. Sti. (2025) Summary page 5.

## Indications for use
HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level(C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and implanted with auto graft/autologous bone graft. They are to be used with supplemental fixation. HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.

Source page: https://510kreport.com/device/K260340
Methodology: https://510kreport.com/methodology