PERLA® TL Posterior Thoraco-lumbar Fixation System
K253966 · Spineart SA · NKB · May 1, 2026 · Orthopedic
Device Facts
Record ID
K253966
Device Name
PERLA® TL Posterior Thoraco-lumbar Fixation System
Applicant
Spineart SA
Product Code
NKB · Orthopedic
Decision Date
May 1, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The PERLA® TL Posterior Thoraco-lumbar Fixation 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 Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation 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 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.
Device Story
PERLA® TL is a posterior thoraco-lumbar fixation system comprising screws, rods, set screws, hooks, rod connectors, and cross-connectors. Components are configured and rigidly locked to rods to stabilize spinal segments. Used in OR by surgeons; implants are sterile (gamma); instruments are reusable. System provides mechanical stabilization; when augmented with TEKTONA® HV US bone cement, it restores spinal column integrity in patients with advanced tumors where fusion is not feasible. Benefits include spinal stabilization and pain relief from pathological fractures.
Clinical Evidence
No clinical testing was required for this device. Substantial equivalence is supported by non-clinical bench testing, including static compression, static torsion, dynamic compression (ASTM F1717), static axial/torsion gripping (ASTM F1798), and MRI compatibility (ASTM F2503).
Technological Characteristics
Materials: Titanium alloy (ASTM F136) and cobalt chromium (ASTM F1537). Components: Screws, rods, set screws, hooks, rod connectors, cross-connectors. Sterilization: Gamma radiation for implants. Mechanical testing per ASTM F1717 and F1798. MRI compatibility per ASTM F2503. Endotoxin limit: 20 EU/device.
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization/stabilization as adjunct to fusion for degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis. Also indicated for pediatric adolescent idiopathic scoliosis (posterior approach only). When used with TEKTONA® HV US bone cement, indicated for patients with advanced thoracic/lumbar spine tumors with limited life expectancy where fusion is not achievable. TEKTONA® HV US bone cement also indicated for pathological vertebral fractures due to osteoporosis, benign lesions, or malignant lesions.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 1, 2026
Spineart SA
Estelle Lefeuvre
Regulatory & Market Access Manager
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates, 1228
Switzerland
Re: K253966
Trade/Device Name: PERLA® TL Posterior Thoraco-lumbar Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral Pedicle Screw System
Regulatory Class: Class II
Product Code: NKB, KWP
Dated: December 11, 2025
Received: December 11, 2025
Dear Estelle Lefeuvre:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K253966 - Estelle Lefeuvre
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K253966 - Estelle Lefeuvre
Page 3
Sincerely,
COLIN
O'NEILL -S
Colin O'Neill, M.B.E.
Acting Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253966
Device Name
PERLA® TL Posterior Thoraco-lumbar Fixation System
Indications for Use (Describe)
The PERLA® TL Posterior Thoraco-lumbar Fixation 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 Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation 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
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.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
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FORM FDA 3881 (8/23)
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K253966
| 510(k) #: K253966 | 510(k) Summary | Prepared on: 2026-04-14 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Spineart SA | |
| Applicant Address | Chemin du Pré-Fleuri 3 Plan-les-Ouates 1228 Switzerland | |
| Applicant Contact Telephone | 0041225701203 | |
| Applicant Contact | Mrs. Estelle Lefeuvre | |
| Applicant Contact Email | elefeuvre@spineart.com | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | PERLA® TL Posterior Thoraco-lumbar Fixation System | |
| Common Name | Thoracolumbosacral pedicle screw system | |
| Classification Name | Thoracolumbosacral Pedicle Screw System | |
| Regulation Number | 888.3070 | |
| Product Code(s) | NKB, KWP, PML | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K193396 | PERLA® TL | NKB |
| K203222 | PERLA® TL | NKB |
| K213470 | PERLA® TL | NKB |
| K231069 | PERLA® TL | NKB |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile except for the drill supplied as sterile or not sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Thoraco-lumbar Fixation System manufactured by Spineart (K193396, K203222, K203506, K213470, K230774, K231069) consists of addition of: - Screws: Pelvic Screws and Dual Rod Polyaxial Screws - Rod connectors: Articulated Rod Connectors - Setscrews: Pelvic Setscrews | | |
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K253966
# Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The PERLA® TL Posterior Thoraco-lumbar Fixation 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 Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation 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
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.
# Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject devices have the same intended use and indications for use, as the following PERLA TL predicates:
- K193396, S.E. 12/06/2019
- K203222, S.E. 11/02/2020
- K213470, S.E. 10/28/2021
- K231069, S.E. 04/14/2023
# Technological Comparison
21 CFR 807.92(a)(6)
As was established in this submission, the PERLA® TL added components are substantially equivalent and have the same technological characteristics to predicate devices in areas including materials, similar overall design, range of sizes, mechanical performance and sterilization.
# Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Spineart has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
The subject devices have been tested or rationalized based on if Spineart believes that testing is not warranted for the subject devices as they do not present a new worst-case when compared to the predicates.
Testing and/or rationales were completed for the following:
- ASTM F1717: Static compression, static torsion, and dynamic compression
- ASTM F1798: Static axial gripping and static axial torsion gripping
- ASTM F2503: MRI compatibility evaluation
For the tested subject devices, the pre-determined acceptance criteria was met for all tests. For subject devices that are rationalized, all existing predicate data previously provided in the predicate 510(k) is still applicable.
Therefore, Spineart believes the design verification testing demonstrated that the subject devices are substantially equivalent to the predicate device.
No clinical testing was required for the subject device.
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K253966
The data included in this submission demonstrate substantial equivalence to the predicate devices. PERLA® TL System is as safe, as effective, and performs as well as, or better, than the predicate devices.
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