FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Resurfacing technique.
    - Degree of constraint.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Arthroscope.
    - AC-powered dynamometer.
    - Nonpowered dynamometer.
    - Goniometer.
    - Nonpowered goniometer.

Subpart C [Reserved]

    - Bone cap.
    - Bone fixation cerclage.
    - Bone heterograft.
    - Intramedullary fixation rod.
    - In vivo cured intramedullary fixation rod.
    - Passive tendon prosthesis.
    - Polymethylmethacrylate (PMMA) bone cement.
    - Single/multiple component metallic bone fixation appliances and accessories.
    - Smooth or threaded metallic bone fixation fastener.
    - Screw sleeve bone fixation device.
    - Resorbable calcium salt bone void filler device.
    - Spinal interlaminal fixation orthosis.
    - Spinal intervertebral body fixation orthosis.
    - Thoracolumbosacral pedicle screw system.
    - Posterior cervical screw system.
    - Intervertebral body fusion device.
    - Intraoperative orthopedic strain sensor.
 - Ankle joint metal/composite semi-constrained cemented prosthesis.
    - Ankle joint metal/polymer semi-constrained cemented prosthesis.
    - Ankle joint metal/polymer non-constrained cemented prosthesis.
    - Elbow joint metal/polymer constrained cemented prosthesis.
    - Elbow joint metal/polymer semi-constrained cemented prosthesis.
    - Elbow joint radial (hemi-elbow) polymer prosthesis.
    - Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
    - Finger joint metal/metal constrained uncemented prosthesis.
    - Finger joint metal/metal constrained cemented prosthesis.
    - Finger joint metal/polymer constrained cemented prosthesis.
    - Finger joint polymer constrained prosthesis.
    - Hip joint metal constrained cemented or uncemented prosthesis.
    - Hip joint metal/polymer constrained cemented or uncemented prosthesis.
    - Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
    - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
    - Hip joint metal/composite semi-constrained cemented prosthesis.
    - Hip joint metal/polymer semi-constrained cemented prosthesis.
    - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
    - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
    - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
    - Hip joint (hemi-hip) acetabular metal cemented prosthesis.
    - Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
    - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
    - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
    - Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
    - Knee joint femorotibial metallic constrained cemented prosthesis.
    - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
    - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
    - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
    - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
    - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
    - Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
    - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
    - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
    - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
    - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
    - Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
    - Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

  - Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
    - Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
    - Shoulder joint metal/polymer non-constrained cemented prosthesis.
    - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
    - Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
    - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
    - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
    - Toe joint polymer constrained prosthesis.
    - Toe joint phalangeal (hemi-toe) polymer prosthesis.
    - Wrist joint carpal lunate polymer prosthesis.
    - Wrist joint carpal scaphoid polymer prosthesis.
    - Wrist joint carpal trapezium polymer prosthesis.
    - Wrist joint polymer constrained prosthesis.
    - Wrist joint metal constrained cemented prosthesis.
    - Wrist joint metal/polymer semi-constrained cemented prosthesis.
    - Wrist joint ulnar (hemi-wrist) polymer prosthesis.

    - Calipers for clinical use.
    - Cement dispenser.
    - Cement mixer for clinical use.
    - Cement monomer vapor evacuator.
    - Cement ventilation tube.
    - Depth gauge for clinical use.
    - Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
    - Orthopedic manual surgical instrument.
    - Sonic surgical instrument and accessories/attachments.
    - Protractor for clinical use.
    - Template for clinical use.
    - Nonpowered orthopedic traction apparatus and accessories.
    - Noninvasive traction component.
    - Cast component.
    - Cast removal instrument.
    - Manual cast application and removal instrument.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l , 371.
Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

Extracted from US.FDA