(234 days)
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Not Found
No
The provided text describes a pedicle screw system for spinal fusion and fixation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the mechanical function and intended use of the surgical implants.
Yes
The device is a pedicle screw system used to treat severe spondylolisthesis and other spinal conditions, aiming to achieve fusion and alleviate pain, which is consistent with a therapeutic purpose.
No
Explanation: The device description indicates it is a pedicle screw system intended for treatment and fixation, not for diagnosing medical conditions.
No
The device description is not found, but the intended use clearly describes a "pedicle screw system" and "implants," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fusion and fixation. This is a therapeutic device, not a diagnostic one.
- Device Description (Not Found, but implied by intended use): While the description is missing, the intended use points to a physical implant (pedicle screw system). IVDs are typically reagents, kits, or instruments used to examine specimens from the human body.
- No mention of biological specimens: The information does not mention the analysis of blood, urine, tissue, or any other biological specimen, which is a core characteristic of IVDs.
- Anatomical Site: The anatomical sites mentioned are parts of the spine, where the device is implanted. IVDs are used to analyze specimens from the body, not implanted in the body for treatment.
Therefore, the Wiltse System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wiltse System Is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformittes (including scollosis, kyphosis, and lordosis), tumor, pseudoarthrosis, and revision of failed previous fusion surgery. Other indications include degenerative lumbar scollosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
Product codes
KWQ, MNH
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), noncervical spine, S1 or S2 locations (sacral screws), L1 to L5 (sublaminar wire fixation)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
orthopedic surgeon specializing in spinal surgery.
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
FEB 4 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greg Holland Consultant to Advanced Spine Fixation Systems, Inc. Holland & Associates 3722 Avenue Sausalito Irvine, California 92606
Re: K992012
Wiltse System Regulatory Class: II Product Code: KWQ and MNH Dated: November 2, 1999 Received: November 9, 1999
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
1
Page 2 - Mr. Greg Holland
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R Ogden
James E. Dillard III
James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of _1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Willse Device Name:_
Indications For Use
The Wiltse System Is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformittes (including scollosis, kyphosis, and lordosis), tumor, pseudoarthrosis, and revision of failed previous fusion surgery. Other indications include degenerative lumbar scollosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
The Wiltse System is intended for use by the orthopedic surgeon specializing in spinal surgery. Advanced Spine Fixation Systems Incorporated personnel are available to provide specialized training for surgeons in the use of the device. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | NRO for Jzp |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992012 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |