Legal Issues in Spine Care
The NASS office continues to receive calls about the status of pedicle screw systems. So we had the Collins Law Firm identify approved Pedicle Screw Systems. The following is the result of that effort. A series of documents are included in this report, including:
- Labeling. A page describing the labeling for any device approved under the new FDA Final Rule. This indicates the labeling that will appear on all pedicle screw devices approved under the new Rule.
- Final FDA Rule. A copy of 21 CFR §888.3070. This is the new section of the Code dedicated to Pedicle Screw Systems.
Coming up with the Schedule of approved Pedicle Screw Systems was difficult because, incredibly, there is no single source of information to be consulted on this matter. Rather, as described in the Background below, a variety of sources had to be consulted.
Therefore, while we are confident that this Schedule identifies approved Systems, we cannot be completely confident that it identifies all approved Systems. For that reason, we also include the "labeling" language. The bottom line is that, for any System approved under the new FDA Rule, it bears this language.
On July 27, 1998, the FDA issued its Final Rule entitled "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems" (Final FDA Rule.) This rule reclassified certain pedicle screw systems as Class II devices, and created a new section of the Code of Federal Regulations, 21 CFR §888.3070. According to Mark Melkerson of the FDA, the Final Rule covers four FDA product codes:
- KWQ - Appliance, Fixation, Spinal Intervertebral Body
- KWP - Appliance, Fixation, Spinal Interlaminal
- MNH - Orthosis, Spondylolisthesis Spinal Fixation
- MNI - Orthosis, Spinal Pedicle Fixation
Mr. Melkerson and Aric Kaiser, the FDA-assigned contact regarding the Final Rule, both confirmed that the FDA does not maintain a list of devices approved under this Rule. In addition, both indicated that development of such a list would be a difficult undertaking, due to the inherent complexity of Food and Drug Law.
Therefore, in order to develop a list ourselves, we began consulting the FDA’s web site. Here, it posts summaries of all approved 510(k) submissions.1 These summaries typically consist of a portion of the manufacturer’s 510(k) submission, the FDA’s letter to the manufacturer granting permission to market that device, and a page of approved indications.
Each of the devices on the attached list have a listing (Approved Systems) in the FDA’s Releasable 510(k) Database. For each of the four product codes covered by the Final Rule, we completed a search in the Releasable 510(k) Database from the date of the Final Rule to present. The summary for each device located by the search was downloaded and printed. The documentation provided by the manufacturer was reviewed, and if the language of that documentation tracked the indications language of 21 CFR §888.3070, the device was placed on the attached Schedule. The specific language found on each device can be found under Labeling.
1 As you know, a Class II device requires a 510(k) premarket notification. This means that the manufacturer must apply to the FDA for an order granting permission to market the device prior to actually marketing it or prior to substantially changing the intended use of previously cleared device. Marketing without such an order is illegal. The thrust of this premarket notification is that the manufacturer must show its device to be substantially equivalent to one or more predicate devices (ie, already existing and cleared devices with the same intended use and either the same technological characteristics or different technological characteristics but no new questions of safety). After such an order has been received, any future modification that could affect safety or effectiveness of the cleared device or any future change in intended use must be provided to the FDA in the form of a 510(k) submission.