Joint, Knee, External Brace
FDA product code ITQ · Class I (low risk) · 21 CFR 890.3475 · Physical Medicine
15510(k) clearances
0PMA approvals
11recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823658 | Deluxe Knee Immobilizer(Universal)ITQ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | Aircast, Inc. | 08/13/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | Surgical Appliance Industries, Inc. | 06/25/1981SE |
| K810222 | Limb OrhtosisITQ · Traditional | Medical Design & Manufacturing Corp. | 02/04/1981SE |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
| K772271 | Walker Folding AdjustableITQ · Traditional | Med Fusion Systems, Inc. | 12/20/1977SE |
| K772270 | Setup Walker Over Toilet Construc.ITQ · Traditional | Med Fusion Systems, Inc. | 12/20/1977SE |
| K772269 | Setup Walker AdjustableITQ · Traditional | Med Fusion Systems, Inc. | 12/20/1977SE |
| K772268 | Demi-Walker (Regular)ITQ · Traditional | Med Fusion Systems, Inc. | 12/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2475-2020 Class II | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per boxNatural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". | Mueller Sports Medicine, Inc | 06/18/2020Terminated |
| Z-0706-2020 Class II | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPPThe Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. | DeRoyal Industries Inc | 11/21/2019Open, Classified |
| Z-1286-2016 Class II | Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for…Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar… | Ossur H / F | 02/24/2016Terminated |
| Z-0580-2016 Class II | CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0579-2016 Class II | ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0578-2016 Class II | BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0577-2016 Class II | ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0576-2016 Class II | HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0575-2016 Class II | CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-0574-2016 Class II | Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace…Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension… | Corflex | 11/12/2015Terminated |
| Z-1665-2015 Class II | Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes…The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction | United Surgical Associates | 04/13/2015Terminated |