PERLA® TL posterior osteosynthesis system— 510(k) K193396

Clearance details

Applicant

Spineart

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2019-12-06

Decision date

2020-02-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plan Les Ouates, CH

• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement2023-06-23
• K213470 — PERLA® TL Posterior Osteosynthesis System2022-01-21
• K210472 — SPINEART Navigation Instrument System2021-03-19
• K203506 — PERLA® TL posterior osteosynthesis system2021-01-15
• K203222 — PERLA TL Posterior Osteosynthesis System2020-12-17

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1758-2024 — PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S 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 (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis).Class II·Ongoing·SPINEART SA·20240315
• Z-1975-2021 — PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mmClass II·Terminated·SPINEART SA·20210409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193396.