(106 days)
Not Found
No
The description focuses on the mechanical components and intended use of a pedicle screw system, with no mention of AI or ML capabilities.
Yes
The device is described as an "adjunct to fusion" and is intended to "help provide correction, immobilization and stabilization of spinal segments" for various medical conditions, indicating its use in treating health problems.
No
The device description clearly states its purpose as providing "correction, immobilization and stabilization of spinal segments as an adjunct to fusion," indicating its therapeutic use in surgery, not diagnosis.
No
The device description clearly states it consists of physical components like rods and screws made of titanium alloy, which are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The LEUCADIA AUTOLOK™ Pedicle Screw System is a surgical implant. It is a physical device designed to be placed inside the body to provide structural support and stabilization to the spine.
- Intended Use: The intended use clearly describes its function as an "adjunct to fusion using autograft or allograft in posterior, non-cervical fixation" for various spinal conditions. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
The information provided describes a medical device used for surgical intervention and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor, pseudarthrosis; and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Leucadia AutoLok™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Multi-axial AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter sizes. All sizes can receive 5.5mm connecting rods only. The unique pedicle screw and set screw interface is designed to prevent backout of the set screw from the construct. The Leucadia AutoLok™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent.
The Leucadia AutoLok™ Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia AutoLok™ Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia AutoLok™ Pedicle Screw System components should not be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation (thoracic, lumbar and/or sacral space)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical tests according to ASTM F1717-15 (Static Compression Bending, Static Torsion, and Dynamic Compression Bending) have been performed. The test results were equivalent to the predicate device(s) and other similar implants legally marketed and are sufficient for in vivo loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
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.
(b)
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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December 12, 2018
ClearView Orthopedic Development, LLC Mr. Hartmut Loch Vice President, Regulatory Affairs & Quality Assurance 15550-D Rockfield Boulevard Irvine, California 92618
Re: K182339
Trade/Device Name: LEUCADIA AUTOLOK™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 7, 2018 Received: November 13, 2018
Dear Mr. Loch:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182339
Device Name LEUCADIA AUTOLOK™ Pedicle Screw System
Indications for Use (Describe)
The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions:
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor, pseudarthrosis; and/or failed previous fusion.
| 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) |
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| Contact: | Mr. Hartmut Loch, RAC
Vice President, Regulatory Affairs & Quality Assurance
ClearView Orthopedic Development, LLC
15550-D Rockfield Blvd
Irvine CA 92618
Tel: 1-949-752-7885 x 104
Fax: 1-949-752-7886 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 11, 2018 |
| Trade name: | LEUCADIA AutoLok™ Pedicle Screw System |
| Common name: | Spinal Fixation System |
| Classification
name: | § 888.3070 - Thoracolumbosacral Pedicle Screw System (NKB) |
| Regulatory Class: | II |
| Device Panel: | Orthopedic Device Panel 87 |
| Product Code(s): | NKB |
| Device Description
and Characteristics: | The Leucadia AutoLok™ Pedicle Screw System is intended to help provide
correction, immobilization and stabilization of spinal segments as an adjunct
to fusion of the thoracic, lumbar and/or sacral space.
The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods
and screws, which can be rigidly locked into a variety of configurations, with
each construct being tailor made for the individual case. The Multi-axial
AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter
sizes. All sizes can receive 5.5mm connecting rods only. The unique
pedicle screw and set screw interface is designed to prevent backout of the
set screw from the construct. The Leucadia AutoLok™ Pedicle Screw
System implant components are fabricated from medical grade titanium alloy
(Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent.
The Leucadia AutoLok™ Pedicle Screw System is a temporary implant
system, intended to be removed after solid fusion has occurred. Leucadia
AutoLok™ Pedicle Screw System implant components should not be used
with components from any other system or manufacturer. As with all
orthopedic implants, Leucadia AutoLok™ Pedicle Screw System
components should not be reused. |
| Indications: | The LEUCADIA AUTOLOK™ Pedicle Screw System is intended to be used
as an adjunct to fusion using autograft or allograft in posterior, non-cervical
fixation for the following conditions: degenerative disc disease (defined as
back pain of discogenic origin with degeneration of the disc confirmed by
history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or
dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or
lordosis); tumors; pseudarthrosis; and/or failed previous fusion. |
| Equivalence: | The modified LEUCADIA AUTOLOK™ Pedicle Screw System is
substantially equivalent to the following marketed systems:
- Leucadia AutoLok™ Pedicle Screw System K113366 S/E 1/17/2012
(Primary) - Leucadia Pedicle Screw System K103102 S/E 2/8/2011 (Additional)
- Leucadia Pedicle Screw System K110588 S/E 5/25/2011(Additional)
They are all manufactured and marketed by ClearView Orthopedic
Development, LLC, formerly Phygen, LLC. |
| | The subject System has been slightly redesigned, regarding the locking
interfaces between the pedicle screw, the AutoLok™ pedicle screw head and
the AutoLok™ set screw/locking nut in order to assure maximum stability of
the construct under worst case tolerances. |
| | The indications for use, sizes and varieties of components, materials, type of
sterilization, surgical techniques, and manufacturing processes have not
changed and are identical to the predicate device (s). |
| Performance data: | Biomechanical tests according to ASTM F1717-15 (Static Compression
Bending, Static Torsion, and Dynamic Compression Bending) have been
performed. The test results were equivalent to the predicate device(s) and
other similar implants legally marketed and are sufficient for in vivo loading. |
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