(30 days)
The LEUCADIA™ 4.5 mm 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.
The Leucadia™ 4.5 mm 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™ 4.5 mm Pedicle Screw System consists of 4.5 mm diameter screws, which are available in 7 different lengths: 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. All sizes are able to receive 5.5mm connecting rods only. The Leucadia™ 4.5 mm Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ 4.5 mm Pedicle Screw System is a temporary implant system intended to be removed after solid fusion has occurred. Leucadia™ 4.5 mm Pedicle Screw System implant components are an addition to the existing Leucadia™ Pedicle Screw System (K110588 - S/E May 25, 2011). It should not be used with components from any other manufacturer. As with all orthopedic implants, Leucadia™ 4.5 mm Pedicle Screw System components should not be reused.
The Leucadia™ 4.5 mm Pedicle Screw System is intended to help correct, immobilize, and stabilize spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral space.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Device K110588) | Reported Device Performance (LEUCADIA™ 4.5 mm Pedicle Screw System) |
|---|---|
| Mechanical tests equivalent to or better than the predicate device for static compression bending, static torsion, dynamic compression bending, and screw pullout. | Test results for Static Compression Bending, Static Torsion, Dynamic Compression Bending, and Screw Pullout per ASTM F1717-10 and ASTM F543-07 were confirmed to be equivalent to the predicate device and/or other similar implants. The results are sufficient for in vivo loading. |
2. Sample size used for the test set and the data provenance
The sample size is not explicitly stated, but the testing involved biomechanical tests compliant with ASTM standards. The data provenance is from laboratory testing of the device and its predicate, conducted by Phygen, LLC, a US-based company. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and qualifications
Not applicable. The ground truth for this device is based on standardized biomechanical testing (ASTM standards), not expert medical opinion on clinical images or patient data.
4. Adjudication method for the test set
Not applicable. This device relies on objective mechanical testing against established industry standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case comparative effectiveness study was not done. This is a medical device (spinal implant) and its performance is evaluated through biomechanical testing, not through human reader interpretation of data or images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a "standalone" evaluation was performed, meaning the device's mechanical properties were tested independently without human interaction influencing the test results.
7. The type of ground truth used
The ground truth used for proving the device meets acceptance criteria is based on:
- Established ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F1717-10 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending, and ASTM F543-07 for Screw Pullout Tests. These standards define the methodologies and expected performance parameters for spinal implant devices.
- Comparative equivalence: The device's performance was compared against the predicate device (LEUCADIA™ Pedicle Screw System, K110588) and/or other similar implants, demonstrating equivalent mechanical properties sufficient for in vivo loading.
8. The sample size for the training set
Not applicable. This device is a mechanical implant; therefore, no "training set" in the context of machine learning or AI is relevant.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
MAR - 7 2012
| Contact: | Mr. Hartmut LochVice President, Regulatory Affairs & Quality AssurancePhygen, LLC.2301 Dupont Drive, Suite 510Irvine CA 92612Tel: 1-949-752-7885 x 117. – Fax: 1-949-752-7886 | |
|---|---|---|
| Date Prepared: | February 3, 2012 | |
| Trade name: | LEUCADIA™ 4.5 mm Pedicle Screw System | |
| Common name: | Spinal Fixation System | |
| Classificationname: | § 888.3070 - Orthosis, Spinal Pedicle Fixation, For Degenerative DiscDisease§ 888.3050 - Appliance, Fixation, Spinal Interlaminal§ 888.3060 - Spinal Intervertebral Body Fixation Orthosis§ 888.3070 - Pedicle Screw Spinal System§ 888.3070 - Pedicle Screw Spinal System | (NKB) - Class III(KWP) - Class II(KWQ) - Class II(MNI) - Class II(MNH) - Class II |
| All Orthopedic Device Panel 87 | ||
| Product Code (s): | NKB, KWP, KWQ, MNI, & MNH | |
| Device Descriptionand Characteristics: | The Leucadia™ 4.5 mm Pedicle Screw System is intended to help providecorrection, immobilization and stabilization of spinal segments as an adjunctto fusion of the thoracic, lumbar and/or sacral space. | |
| The Leucadia™ 4.5 mm Pedicle Screw System consists of 4.5 mm diameterscrews, which are available in 7 different lengths: 25 mm, 30 mm, 35 mm, 40mm, 45 mm, 50 mm, and 55 mm. All sizes are able to receive 5.5mmconnecting rods only. The Leucadia™ 4.5 mm Pedicle Screw Systemimplant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. | ||
| The Leucadia™ 4.5 mm Pedicle Screw System is a temporary implantsystem intended to be removed after solid fusion has occurred. Leucadia™4.5 mm Pedicle Screw System implant components are an addition to theexisting Leucadia™ Pedicle Screw System (K110588 - S/E May 25, 2011).It should not be used with components from any other manufacturer. As withall orthopedic implants, Leucadia™ 4.5 mm Pedicle Screw Systemcomponents should not be reused. | ||
| Equivalence: | The additional Leucadia™ 4.5 mm screws are substantially equivalent to theLEUCADIA™ Pedicle Screw System (K110588 - S/E May 25, 2011), whichis manufactured and marketed by Phygen, LLC. |
page 1 of 2
{1}------------------------------------------------
120355
The LEUCADIA™ 4.5 mm Pedicle Screw System is intended to be used as Indications: 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.
Biomechanical tests per ASTM F1717-10 (Static Compression Bending, Performance data: Static Torsion, and Dynamic Compression Bending) as well as the Screw Pullout Tests per ASTM F543-07 have been performed. The test results were equivalent to the predicate device and/or other similar implants and are sufficient for in vivo loading.
Special 510(k) Leucadia™ 4.5 mm Pedicle Screw System
Page 2 of 2
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 7 2012
Phygen, LLC % Hartmut Loch Vice President, Regulatory Affairs & Quality Assurance 2301 Dupont Drive #510 Irvine, California 92612
Re: K120355
Trade/Device Name: LEUCADIA™ 4.5 MM Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NKB, MNI, MNH, KWP, KWQ Dated: February 3, 2012 Received: February 6, 2012
Dear Hartmut 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 10 woo nava in 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. The r ou may , alerteres, issions 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 warrenties. 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
{3}------------------------------------------------
Page 2 - Hartmut Loch
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Eunel Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
LEUCADIA™ 4.5 mm Pedicle Screw System Device Name(s):
Indications for Use:
The LEUCADIA™ 4.5 mm 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.
Prescription Use _ X
AND/OR
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 120355 510(k) Number.
of Page
§ 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.