# K230774: PERLA® TL System; TEKTONA® HV US Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jun 23, 2023 after 94 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K003155 (2001). 670 ancestors in all.
No later device cites it as a predicate yet.
1 of 671 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Medtronic Sofamor Danek USA, Incorporated (2016) Summary page 5.
- K213470: PERLA® TL Posterior Osteosynthesis System, Spineart (2022) Summary page 5.
- K122175: Mendec Spine HV, Mendec Spine HV System, Tecres S.P.A. (2013) Summary page 5.
- K212489: BonOs Inject Bone Cement; NEO Pedicle Screw System, Neo Medical SA (2021) Summary page 5.
- K200596: G21 Cement, VADER® Pedicle System, Icotec AG (2020) Summary page 5.

## Indications for use
The PERLA® TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: • degenerative disc disease; • spondylolisthesis; • fracture; • dislocation; • scoliosis; • kyphosis; • spinal tumor; • and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used in conjunction with TEKTONA® HV US bone cement system, the PERLA® TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA® TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised. TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with PERLA® TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA® TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K230774
Methodology: https://510kreport.com/methodology