PERLA® TL System; TEKTONA® HV US Bone Cement
FDA 510(k) K230774 · Spineart
510(k) numberK230774
Submission
- Device name
- PERLA® TL System; TEKTONA® HV US Bone Cement
- Applicant
- Spineart
Geneva, CH - Received
- March 21, 2023
- Decision date
- June 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PML – Bone Cement, Posterior Screw Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to augment the fixation of screws in a posterior spinal system construct.
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|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | Spine Wave, Inc. | 06/15/2026SE |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | Astura Medical | 01/22/2026SE |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML · Traditional | Medacta International S.A. | 06/12/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | Ulrich Medical USA | 10/20/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | Icotec AG | 01/09/2023SE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemPML · Traditional | Alphatec Spine, Inc. | 12/20/2022SE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw SystemPML · Special | Neo Medical SA | 08/26/2022SE |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw SystemPML · Traditional | Neo Medical SA | 10/28/2021SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | Icotec AG | 10/13/2020SE |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone CementPML · Traditional | Medtronic | 08/19/2020SE |
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| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 05/01/2026SE |
| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
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| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
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Questions and answers
When was PERLA® TL System; TEKTONA® HV US Bone Cement cleared by the FDA?
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774) received a 510(k) decision of Substantially Equivalent on June 23, 2023, 94 days after the submission was received.
What is the product code of K230774?
The FDA product code is PML – Bone Cement, Posterior Screw Augmentation, a Class II (moderate risk) device regulated under 21 CFR 888.3027.