FDA Final Rule: Pedicle Screw Systems

The entire final rule (21 CFR Part 888.3070), ssued July 27, 1998, is available on the FDA Web site. The portion regarding pedicle screws is provided here:

PART 888--ORTHOPEDIC DEVICES
1. The authority citation for 21 CFR part 888 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 888.3070 is added to subpart D to read as follows:

Sec. 888.3070 Pedicle screw spinal system. (a) Pedicle screw spinal systems--(1) Identification. Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allows 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 anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. The devices are 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). (2) Classification. Class II (special controls). 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 which 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 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.'' (b) Pedicle screw spinal systems for all other uses--(1) Identification. Pedicle screw spinal systems for all other uses are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni- 5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow [[Page 40041]] the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such an spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. (2) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. An approved PMA or a declared completed PDP must be in effect before placing the device in commercial distribution. See Sec. 888.3.