(119 days)
No
The document describes a mechanical spinal fixation system and explicitly states that it is identical to its predicates with respect to general technological characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "posterior spinal pedicle fixation system" intended to provide "immobilization and stabilization of spinal segments" to treat various spinal conditions, which clearly indicates a therapeutic purpose.
No
The device is a posterior spinal fixation system designed to stabilize spinal segments as an adjunct to fusion, rather than to diagnose medical conditions.
No
The device description explicitly states it is a "posterior spinal pedicle fixation system consisting of various implant components," which are physical hardware implants.
Based on the provided information, the Easyspine® Posterior Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "posterior, non-cervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description confirms it's a "side-loading posterior spinal pedicle fixation system consisting of various implant components." This further reinforces its nature as a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text contains no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Easyspine® Posterior Spinal System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:
- 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 .
- Deformities or curvatures (i.e., scoliosis, kyphosis, . and/or lordosis)
- . Tumor
- Pseudoarthrosis .
- Failed previous fusion ●
Product codes
NKB, MNH, MNI, KWP
Device Description
The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system consisting of various implant components. The 4.25 mm pedicle screws and curved rods represent a line extension to the previously cleared Easyspine Spinal System (K043094, K063794, and K082592). The subject devices are identical to their predicates with respect to general technological characteristics and intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally-mature patients
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)
Non-clinical testing on the proposed Easyspine 4.25 mm pedicle screws included testing in Static and Dynamic Axial Compression and Static Torsion in accordance with (per ASTM F-1717) and Axial Gripping Capacity and Flexion-Extension Cantilever (per ASTM F-1798).
The results of this testing demonstrate that the performance of the proposed LDR Spine Easyspine implants, when compared with their legally marketed predicates, are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043094, K063794, K082592, K121103
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for LDR, which is a company that focuses on innovation. The logo includes the text "K123134" at the top left. The logo also includes a circular graphic with a curved line inside of it. The text "a passion for innovation" is at the bottom of the image.
510(k) Summary
FEB 0 1 2013
Owner's Name & Address:
LDR Spine USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 Phone: (512) 344-3333 Fax: (512) 344-3350
Bradley W. Strasser, RAC Regulatory Affairs Project Manager Phone: (512) 344-3395 Fax: (512) 795-8306 Email: brad.strasser@ldrspine.com
January 28, 2013
Orthopedic
Pedicle Screw Spinal System
111/11
Pedicle Screw Spinal System (per CFR 888.3070)
NKB (per 21 CFR 888.3070)- Orthosis, spinal pedicle fixation, for degenerative disc disease MNH (per CFR 888.3070)- Orthosis, Spondilolisthesis, Spinal Fixation MNI (per CFR 888.3070)- Orthosis, Spinal Pedicle Fixation KWP (per CFR 888.3050)- Orthosis, Spinal Interlaminal Fixation
LDR Spine Easyspine Posterior Spinal System
LDR Spine Easyspine Posterior Spinal System
- K043094, cleared February 11, 2005 .
- K063794, cleared January 24, 2007 .
- . K082592, cleared October 8, 2008
- K121103, cleared August 24, 2012 .
Synthes Spine Matrix System
Date:
Review Panel:
Contact Person:
Common Name:
Classification:
Classification Name:
Product Codes:
Proprietary Name:
Legally Marketed Predicate Device:
1
Image /page/1/Picture/1 description: The image shows the logo for LDR, which is a company that specializes in innovation. The logo includes the text "K123134" at the top left. The logo also includes a graphic of a swirl and the text "a passion for innovation" at the bottom.
Device Description:
Indications for Use:
Non-Clinical Testing:
Conclusion:
The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system consisting of various implant components. The 4.25 mm pedicle screws and curved rods represent a line extension to the previously cleared Easyspine Spinal System (K043094, K063794, and K082592). The subject devices are identical to their predicates with respect to general technological characteristics and intended use.
The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:
- 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 .
- Deformities or curvatures (i.e., scoliosis, kyphosis, . and/or lordosis)
- . Tumor
- Pseudoarthrosis .
- Failed previous fusion ●
Non-clinical testing on the proposed Easyspine 4.25 mm pedicle screws included testing in Static and Dynamic Axial Compression and Static Torsion in accordance with (per ASTM F-1717) and Axial Gripping Capacity and Flexion-Extension Cantilever (per ASTM F-1798).
The results of this testing demonstrate that the performance of the proposed LDR Spine Easyspine implants, when compared with their legally marketed predicates, are substantially equivalent.
The Easyspine Posterior Spinal System has demonstrated substantial equivalence to previously cleared devices with respect to its indications and fundamental scientific technology.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and tail feathers flowing downwards.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 1, 2013
LDR Spine USA % Bradley W. Strasser, RAC Regulatory Affairs Project Manger 13785 Research Boulevard, Suite 200 Austin, Texas 78750
Re: K123134
Trade/Device Name: Easyspine Posterior Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNH. MNI. KWP Dated: October 1, 2012 Received: November 5, 2012
Dear Mr. Strasser:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Bradley W. Strasser, RAC
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Easyspine Posterior Spinal System
Indications for Use:
The Easyspine® Posterior System is a posterior, non-cervical pedicle and nonpedicle system intended to provide immobilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine:
- 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 .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ●
- Tumor ●
- Pseudoarthrosis .
- Failed previous fusion ●
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123134