(93 days)
Not Found
No
The device description and performance studies focus on mechanical components and testing, with no mention of AI or ML.
No.
This device is a spinal fixation system intended to provide immobilization and stabilization as an adjunct to fusion, not to directly treat or cure a disease or condition itself.
No
The device is described as a "spinal fixation system" intended for "immobilization and stabilization of spinal segments" and for "surgical correction of various spinal deformities and pathologies," which indicates it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states it consists of physical components like polyaxial screws, set screws, rods, and cross connectors, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Spondy™ Spinal Fixation System Function: The description clearly states that the Spondy™ Spinal Fixation System is a surgical implant used to stabilize and immobilize spinal segments. It is a physical device implanted into the body, not a device used to analyze samples outside the body.
The information provided describes a surgical implant for spinal fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Spondy Spinal Fixation System is a posterior, noncervical pedicle fixation 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 or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (levels are L3-sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Product codes
MNI, MNH
Device Description
The Spondy Spinal Fixation System is a top-loading spinal fixation system consisting of polyaxial screws, set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbosacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbosacral iliac portion of the spine, thoracic, lumbar and sacral spine, L5-S1 vertebra, L3-sacrum/ilium
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)
Performance data was submitted to characterize the Spondy Spinal Fixation System. Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Testing consisted of Static Compression Bending Testing per ASTM F1717, Dynamic Compression Bending Testing per ASTM F1717, Static Tension Testing per ASTM F1717, and Static Torsion Testing per ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091725, K024096, K051216, K950099, K041449
Reference Device(s)
Not Found
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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100956 Page 1/2
PREMARKET NOTIFICATION 510(K) SUMMARY
JUL--9 2010
Company:
Allure Spine L.L.C. Owner, Regulatory Affairs and Quality Assurance 9214 Sandpiper Drive Charlotte, NC 28277 (440) 339-8709 Telephone: (704) 220-0515 Fax:
Company Contact:
Date:
Trade/Device Name: Regulatory Number: Requlation Name Regulatory Classification: FDA Product Code : Classification Advisory Committee : Review Advisory Committee;
Julia Eller
March 29, 2010
Spondy™ Spinal Fixation System Orthosis 21 CFR 888.3070 Pedicle Screw Spinal System Class II MNI, MNH Orthopedic Orthopedic
Device Description:
The Spondy Spinal Fixation System is a top-loading spinal fixation system consisting of polyaxial screws, set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbosacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy.
Indications for Use/Intended Use:
The Spondy Spinal Fixation System is a posterior, noncervical pedicle fixation 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 or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft
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100956 Page 2/2
only having the device attached to the lumbar and sacral spine (levels are L3-sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Predicate Device:
Predicate device information is included. The Spondy Spinal Fixation System is substantially equivalent to the predicate devices: Perfix™ Spinal System (K091725), The OPTIMA™ Spinal System (K024096), the HydraLok™ (K051216), and the Synergy VLS (K950099, K041449).
Performance Data:
Performance data was submitted to characterize the Spondy Spinal Fixation System. Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Testing consisted of Static Compression Bending Testing per ASTM F1717, Dynamic Compression Bending Testing per ASTM F1717, Static Tension Testing per ASTM F1717, and Static Torsion Testing per ASTM F1717.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
....
JUL -- 9 2010
Allure Spine, L.L.C. % Ms. Julia Eller Regulatory Affairs, Quality Assurance 9214 Sandpiper Drive Charlotte, North Carolina 28277
Re: K100956
Trade/Device Name: SPONDY™ SPINAL FIXATION SYSTEM Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: June 24, 2010 Received: June 29, 2010
Dear Ms. Eller:
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
3
Page 2 - Ms. Julia Eller
CFR Part 807): labeling (21 CFR Part 801): medical device 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 yours.
Barbara Boehm
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use/Intended Use Statement
510(k) Number (if known): K100956
Device Name:
SPONDY™ SPINAL FIXATION SYSTEM
Indications for Use:
The Spondy™ Spinal Fixation System is a posterior, non-cervical pedicle fixation 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 or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/illium), who are having the device removed after the attainment of a solid fusion.
Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
K100956/Supplement 1