Prosthetic Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Orthopedic Devices
  7. Prosthetic Devices

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Section
888.3000

Bone cap.

Section
888.3010

Bone fixation cerclage.

Section
888.3015

Bone heterograft.

Section
888.3020

Intramedullary fixation rod.

Section
888.3023

In vivo cured intramedullary fixation rod.

Section
888.3025

Passive tendon prosthesis.

Section
888.3027

Polymethylmethacrylate (PMMA) bone cement.

Section
888.3030

Single/multiple component metallic bone fixation appliances and accessories.

Section
888.3040

Smooth or threaded metallic bone fixation fastener.

Section
888.3043

Screw sleeve bone fixation device.

Section
888.3045

Resorbable calcium salt bone void filler device.

Section
888.3050

Spinal interlaminal fixation orthosis.

Section
888.3060

Spinal intervertebral body fixation orthosis.

Section
888.3070

Thoracolumbosacral pedicle screw system.

Section
888.3075

Posterior cervical screw system.

Section
888.3080

Intervertebral body fusion device.

Section
888.3090

Intraoperative orthopedic strain sensor.

Section
888.3100

Ankle joint metal/composite semi-constrained cemented prosthesis.

Section
888.3110

Ankle joint metal/polymer semi-constrained cemented prosthesis.

Section
888.3120

Ankle joint metal/polymer non-constrained cemented prosthesis.

Section
888.3150

Elbow joint metal/polymer constrained cemented prosthesis.

Section
888.3160

Elbow joint metal/polymer semi-constrained cemented prosthesis.

Section
888.3170

Elbow joint radial (hemi-elbow) polymer prosthesis.

Section
888.3180

Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

Section
888.3200

Finger joint metal/metal constrained uncemented prosthesis.

Section
888.3210

Finger joint metal/metal constrained cemented prosthesis.

Section
888.3220

Finger joint metal/polymer constrained cemented prosthesis.

Section
888.3230

Finger joint polymer constrained prosthesis.

Section
888.3300

Hip joint metal constrained cemented or uncemented prosthesis.

Section
888.3310

Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Section
888.3320

Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

Section
888.3330

Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Section
888.3340

Hip joint metal/composite semi-constrained cemented prosthesis.

Section
888.3350

Hip joint metal/polymer semi-constrained cemented prosthesis.

Section
888.3353

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Section
888.3358

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Section
888.3360

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

Section
888.3370

Hip joint (hemi-hip) acetabular metal cemented prosthesis.

Section
888.3380

Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

Section
888.3390

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

Section
888.3400

Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

Section
888.3410

Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.

Section
888.3480

Knee joint femorotibial metallic constrained cemented prosthesis.

Section
888.3490

Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

Section
888.3500

Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

Section
888.3510

Knee joint femorotibial metal/polymer constrained cemented prosthesis.

Section
888.3520

Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

Section
888.3530

Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

Section
888.3535

Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

Section
888.3540

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

Section
888.3550

Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

Section
888.3560

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Section
888.3565

Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Section
888.3570

Knee joint femoral (hemi-knee) metallic uncemented prosthesis.

Section
888.3580

Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

Section
888.3590

Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

Section
888.3640

Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.

Section
888.3650

Shoulder joint metal/polymer non-constrained cemented prosthesis.

Section
888.3660

Shoulder joint metal/polymer semi-constrained cemented prosthesis.

Section
888.3670

Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

Section
888.3680

Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Section
888.3690

Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Section
888.3720

Toe joint polymer constrained prosthesis.

Section
888.3730

Toe joint phalangeal (hemi-toe) polymer prosthesis.

Section
888.3750

Wrist joint carpal lunate polymer prosthesis.

Section
888.3760

Wrist joint carpal scaphoid polymer prosthesis.

Section
888.3770

Wrist joint carpal trapezium polymer prosthesis.

Section
888.3780

Wrist joint polymer constrained prosthesis.

Section
888.3790

Wrist joint metal constrained cemented prosthesis.

Section
888.3800

Wrist joint metal/polymer semi-constrained cemented prosthesis.

Section
888.3810

Wrist joint ulnar (hemi-wrist) polymer prosthesis.