SPINEART SA
FDA Regulatory Profile
SPINEART SA appears in FDA public data with 13 recalls, 55 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2279-2025, Class II) was initiated on June 30, 2025. Its most recent 510(k) clearance was granted on May 1, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 55
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2279-2025 | Class II | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Numb | June 30, 2025 |
| Z-2280-2025 | Class II | Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Numb | June 30, 2025 |
| Z-1758-2024 | Class II | 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 | March 15, 2024 |
| Z-1426-2023 | Class II | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12- | March 16, 2023 |
| Z-1975-2021 | Class II | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft | April 9, 2021 |
| Z-0546-2020 | Class III | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | February 5, 2019 |
| Z-0340-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 | November 27, 2017 |
| Z-0341-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 | November 27, 2017 |
| Z-0339-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 | November 27, 2017 |
| Z-0338-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 | November 27, 2017 |
| Z-0337-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 | November 27, 2017 |
| Z-0342-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 | November 27, 2017 |
| Z-0336-2018 | Class II | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 | November 27, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | May 1, 2026 |
| K254158 | SPINEART Navigation Instrument System | April 9, 2026 |
| K242933 | SPINEART Navigation Instrument System | June 18, 2025 |
| K242890 | SPINEART Navigation Instrument System | March 7, 2025 |
| K242589 | Scarlet® AL-T | October 23, 2024 |
| K241644 | SPINEART Navigation Instrument System | August 7, 2024 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | July 18, 2024 |
| K240699 | SCARLET® AC-Ti | May 10, 2024 |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | October 25, 2023 |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | June 23, 2023 |
| K230583 | Tryptik Ti | March 22, 2023 |
| K213470 | PERLA® TL Posterior Osteosynthesis System | January 21, 2022 |
| K210472 | SPINEART Navigation Instrument System | March 19, 2021 |
| K203506 | PERLA® TL posterior osteosynthesis system | January 15, 2021 |
| K203222 | PERLA TL Posterior Osteosynthesis System | December 17, 2020 |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | May 1, 2020 |
| K200312 | Tryptik Ti | April 6, 2020 |
| K193396 | PERLA® TL posterior osteosynthesis system | February 5, 2020 |
| K192993 | SCARLET AL-T | January 22, 2020 |
| K183630 | SPINEART Navigation Instrument System | June 10, 2019 |