Orthopedic (OR) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Orthopedic (OR) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 888, Part 890

Subparts

Part 888 Subpart B—Diagnostic Devices — 11 product codes
Part 888 Subpart D—Prosthetic Devices — 189 product codes
De Novo Classifications — 1 product code
Part 888 Subpart E—Surgical Devices — 70 product codes
Part 890 Subpart F—Physical Medicine Therapeutic Devices — 2 product codes

Product Codes

Product Code	Device Name	Regulation	Class	Devices
HRX	Arthroscope	888.1100	2	680
NBH	Accessories, Arthroscopic	888.1100	1	2
NGR	Tester, Stiffness, Cartilage, Arthroscopic	888.1100	2	2
PPR	Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	888.1100	2	0
LBB	Dynamometer, Ac-Powered	888.1240	2	36
HRW	Dynamometer, Nonpowered	888.1250	1	12
KQX	Goniometer, Ac-Powered	888.1500	1	33
NKI	Goniometer With Electrodes	888.1500	2	1
KQW	Goniometer, Nonpowered	888.1520	1	13
LZE	Isometer	888.1520	1	1
QGQ	Bone Indentation Device	888.1600	2	3
JDT	Cap, Bone	888.3000	1	0
JDQ	Cerclage, Fixation	888.3010	2	129
NDD	Cerclage, Fixation, Metallic	888.3010	2	1
OWI	Bone Fixation Cerclage, Sublaminar	888.3010	2	36
NVC	Bone, Heterograft	888.3015	3	0
HSB	Rod, Fixation, Intramedullary And Accessories	888.3020	2	522
NDE	Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible	888.3020	2	0
SAI	Ankle Fusion Cage	888.3020	2	2
QAD	Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated	888.3023	2	7
HXA	Prosthesis, Tendon, Passive	888.3025	2	11
LOD	Bone Cement	888.3027	2	79
MBB	Bone Cement, Antibiotic	888.3027	2	19
NDN	Cement, Bone, Vertebroplasty	888.3027	2	108
NUD	Vertebroplasty Compound, Calcium Based	888.3027	2	0
OBL	Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty	888.3027	2	1
OBM	Cement, Bone, Vertebroplasty, Pre-Formed, Modular	888.3027	2	0
PML	Bone Cement, Posterior Screw Augmentation	888.3027	2	18
HRS	Plate, Fixation, Bone	888.3030	2	1303
HTN	Washer, Bolt Nut	888.3030	2	92
JDO	Device, Fixation, Proximal Femoral, Implant	888.3030	2	23
JDP	Condylar Plate Fixation Implant	888.3030	2	2
JDR	Staple, Fixation, Bone	888.3030	2	231
JDS	Nail, Fixation, Bone	888.3030	2	53
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	888.3030	2	403
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	888.3030	2	38
KWK	Appliance, Nail/Blade/Plate Combination, Single Component	888.3030	2	1
LRN	Wire, Surgical	888.3030	2	8
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	888.3030	2	57
LYT	Fixation Accessory	888.3030	2	9
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	888.3030	2	219
MNU	Staple, Absorbable	888.3030	2	4
NDF	Plate, Fixation, Bone, Non-Spinal, Metallic	888.3030	2	3
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	888.3030	2	1
NDH	Nail, Fixation, Bone, Metallic	888.3030	2	0
NDI	Staple, Fixation, Bone, Metallic	888.3030	2	0
NOV	Anchor, Suture, Bone Fixation, Metallic	888.3030	2	1
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	888.3030	2	6
OOL	Electronic Depth Gauge	888.3030	2	1
OSN	Software For Diagnosis/Treatment	888.3030	2	4
OZI	Internal Hinged Elbow Fixator	888.3030	2	3
PBF	Orthopaedic Surgical Planning And Instrument Guides	888.3030	2	27
PLF	Bone Wedge	888.3030	2	18
HTY	Pin, Fixation, Smooth	888.3040	2	204
HWC	Screw, Fixation, Bone	888.3040	2	1054
JDW	Pin, Fixation, Threaded	888.3040	2	94
JEC	Component, Traction, Invasive	888.3040	2	85
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	888.3040	2	589
MJW	Prosthesis, Subtalar, Plug, Polymer	888.3040	2	2
MRY	Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component	888.3040	2	0
NDJ	Screw, Fixation, Bone, Non-Spinal, Metallic	888.3040	2	0
NDK	System, External Fixator (With Metallic Invasive Components)	888.3040	2	3
NDL	Pin, Fixation, Smooth, Metallic	888.3040	2	2
NDM	Pin, Fixation, Threaded, Metallic	888.3040	2	1
NJA	Accessory, System, External Fixator, Containing Antimicrobial Agent	888.3040	2	0
NWN	Laparoscopic Bone Anchor Urethropexy Instrument Kit	888.3040	2	0
OUR	Sacroiliac Joint Fixation	888.3040	2	131
OVZ	Pin, Fixation, Resorbable, Hard Tissue	888.3040	2	3
PPQ	Transtibial Anterior Cruciate Ligament Kit	888.3040	2	0
QSR	Sacroiliac Screw Placement Guide	888.3040	2	1
SCY	Sacroiliac Joint Guidewire Placement Device	888.3040	2	1
QJD	Absorbable Metallic Bone Fixation Fastener	888.3041	2	1
QAC	Screw Sleeve Bone Fixation Device	888.3043	2	1
QVI	Screw Sleeve Bone Fixation Device, Spine	888.3043	2	2
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	888.3044	2	3
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	888.3045	2	31
MQV	Filler, Bone Void, Calcium Compound	888.3045	2	489
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	888.3045	2	2
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside	888.3046	2	2
QVL	Absorbable Gel For Intraoperative Use In Spine Surgery	888.3047	2	1
KWP	Appliance, Fixation, Spinal Interlaminal	888.3050	2	430
LYP	Accessories, Fixation, Spinal Interlaminal	888.3050	2	1
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	888.3050	2	29
PEK	Spinous Process Plate	888.3050	2	48
JDN	Implant, Fixation Device, Spinal	888.3060	2	6
KWQ	Appliance, Fixation, Spinal Intervertebral Body	888.3060	2	663
MQP	Spinal Vertebral Body Replacement Device	888.3060	2	277
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	888.3060	2	3
OJM	Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh	888.3060	2	0
PHQ	Anterior Staple As Supplemental Fixation For Fusion	888.3060	2	2
PLR	Spinal Vertebral Body Replacement Device - Cervical	888.3060	2	18
MDI	Prosthesis, Rib Replacement	888.3070	2	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	888.3070	2	309
MNI	Orthosis, Spinal Pedicle Fixation	888.3070	2	303
NKB	Thoracolumbosacral Pedicle Screw System	888.3070	2	892
NQP	Posterior Metal/Polymer Spinal System, Fusion	888.3070	2	22
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	888.3070	2	19
PGM	Growing Rod System	888.3070	2	14
PGN	Growing Rod System- Magnetic Actuation	888.3070	2	9
PQC	Pedicle Screw Placement Guide	888.3070	2	8
QZY	Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating	888.3071	2	1
NKG	Posterior Cervical Screw System	888.3075	2	117
QSD	Posterior Cervical Screw Placement Guide	888.3075	2	2
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	888.3080	2	890
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	888.3080	2	346
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	888.3080	2	198
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	888.3080	2	158
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	888.3080	2	3
OQB	Intervertebral Body Graft Containment Device	888.3085	2	4
QFP	Intraoperative Orthopedic Strain Sensor	888.3090	2	1
KMD	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite	888.3100	2	0
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	888.3110	2	67
OYK	Ankle Arthroplasty Implantation System	888.3110	2	7
KXC	Prosthesis, Ankle, Cemented, Non-Constrained	888.3120	3	0
JDC	Prosthesis, Elbow, Constrained, Cemented	888.3150	2	29
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	888.3160	2	27
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	888.3170	2	33
KWJ	Prosthesis, Elbow, Hemi-, Humeral, Metal	888.3180	3	0
KWE	Prosthesis, Finger, Constrained, Metal, Uncemented	888.3200	3	0
LBC	Prosthesis, Finger, Constrained, Metal, Cemented	888.3210	3	0
KWG	Prosthesis, Finger, Constrained, Metal/Polymer	888.3220	3	1
KWF	Prosthesis, Finger, Polymer	888.3230	2	0
KYJ	Prosthesis, Finger, Constrained, Polymer	888.3230	2	14
KXD	Prosthesis, Hip, Constrained, Metal	888.3300	3	0
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	888.3310	2	36
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	888.3310	2	2
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	888.3320	3	45
LTO	Spacer, Cement	888.3320	3	0
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	888.3330	3	114
KMC	Prosthesis, Hip, Semi-Constrained, Composite/Metal	888.3340	2	3
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	888.3350	2	562
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	888.3350	2	0
PLW	Acetabular Cup Orientation System	888.3350	2	1
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	888.3353	2	529
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	888.3353	2	4
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	888.3353	2	159
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	888.3353	2	4
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	888.3358	2	559
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	888.3358	2	13
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	888.3358	2	20
JDD	Prosthesis, Upper Femoral	888.3360	2	0
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	888.3360	2	59
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	888.3360	2	106
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	888.3360	2	81
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	888.3360	2	8
KWB	Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal	888.3370	3	0
JDH	Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal	888.3380	3	0
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	888.3390	2	99
KXA	Prosthesis, Hip, Femoral, Resurfacing	888.3400	2	23
KXB	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	888.3410	3	0
OCG	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	888.3410	3	0
HRZ	Prosthesis, Knee, Hinged (Metal-Metal)	888.3480	3	0
KRN	Metal Cemented Constrained Femorotibial Knee Prosthesis	888.3480	3	0
KMB	Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented	888.3490	2	0
KTX	Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented	888.3490	2	0
KYK	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	888.3500	2	3
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	888.3510	2	86
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	888.3520	2	114
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	888.3530	2	92
LGE	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing	888.3530	2	2
NJD	Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	888.3535	2	5
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	888.3540	2	27
KRP	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal	888.3550	3	0
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	888.3550	2	0
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	888.3560	2	910
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	888.3560	2	14
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	888.3560	2	12
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	888.3560	2	11
OOG	Knee Arthroplasty Implantation System	888.3560	2	2
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	888.3565	2	142
HSA	Prosthesis, Knee, Hemi-, Femoral	888.3570	3	0
KRS	Prosthesis, Knee, Hemi-, Femoral (Uncemented)	888.3570	3	0
HTG	Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented	888.3580	2	2
HSH	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)	888.3590	2	5
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device	888.3600	2	4
QVV	Medial Knee Implanted Shock Absorber	888.3610	2	1
QPQ	Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed	888.3630	2	1
KWR	Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented	888.3640	3	0
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	888.3650	2	71
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	888.3660	2	190
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	888.3660	2	1
PHX	Shoulder Prosthesis, Reverse Configuration	888.3660	2	200
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	888.3660	2	18
QHE	Shoulder Arthroplasty Implantation System	888.3660	2	24
QHQ	Total Shoulder Arthroplasty System	888.3660	2	1
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	888.3670	2	37
KYM	Metallic Cemented Glenoid Hemi-Shoulder Prosthesis	888.3680	3	0
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	888.3690	2	71
QKW	Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis	888.3695	2	1
KWH	Prosthesis, Toe, Constrained, Polymer	888.3720	2	21
KWD	Prosthesis, Toe, Hemi-, Phalangeal	888.3730	2	46
KWN	Prosthesis, Wrist, Carpal Lunate	888.3750	2	5
KWO	Prosthesis, Wrist, Carpal Scaphoid	888.3760	2	1
KYI	Prosthesis, Wrist, Carpal Trapezium	888.3770	2	26
KIG	Prosthesis, Wrist, Constrained, Polymer	888.3780	2	0
KYN	Prosthesis, Wrist, Constrained, Metal	888.3790	3	0
JWI	Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained	888.3800	2	3
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	888.3800	2	17
KWM	Prosthesis, Wrist, Semi-Constrained	888.3800	2	6
KXE	Prosthesis, Wrist, Hemi-, Ulnar	888.3810	2	16
QZZ	Limb And Joint Salvage Device With Coating For Bacteria Reduction	888.3900	2	2
KTZ	Caliper	888.4150	1	7
KIH	Dispenser, Cement	888.4200	1	11
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	888.4200	1	1
JDZ	Mixer, Cement, For Clinical Use	888.4210	1	13
JDY	Evacuator, Vapor, Cement Monomer	888.4220	1	8
KII	Tube, Cement Ventilation	888.4230	1	0
HTJ	Gauge, Depth	888.4300	1	4
QBO	Instruments Designed For Press-Fit Osteochondral Implants	888.4505	2	2
QHG	Defect Measurement Tool	888.4510	2	1
QLQ	Manual Instruments Designed For Use With Total Disc Replacement Devices	888.4515	2	8
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices	888.4520	2	1
HRR	Scissors, Orthopedic, Surgical	888.4540	1	8
HRT	Stripper, Surgical	888.4540	1	0
HTO	Reamer	888.4540	1	14
HTP	File	888.4540	1	5
HTQ	Broach	888.4540	1	0
HTS	Knife, Orthopedic	888.4540	1	9
HTT	Burr, Orthopedic	888.4540	1	4
HTW	Bit, Drill	888.4540	1	11
HTX	Rongeur	888.4540	1	5
HWA	Impactor	888.4540	1	4
HWB	Extractor	888.4540	1	5
HWD	Starter, Bone Screw	888.4540	1	0
HWI	Corkscrew	888.4540	1	1
HWJ	Awl	888.4540	1	4
HWK	Trephine	888.4540	1	1
HWL	Set, Hollow Mill	888.4540	1	0
HWN	Instrument, Compression	888.4540	1	4
HWO	Skid, Bone	888.4540	1	0
HWP	Punch, Femoral Neck	888.4540	1	1
HWQ	Passer	888.4540	1	9
HWR	Driver, Prosthesis	888.4540	1	4
HWW	Countersink	888.4540	1	0
HWX	Tap, Bone	888.4540	1	2
HXB	Probe	888.4540	1	15
HXC	Wrench	888.4540	1	6
HXE	Fork	888.4540	1	0
HXG	Tamp	888.4540	1	1
HXI	Passer, Wire, Orthopedic	888.4540	1	3
HXJ	Staple Driver	888.4540	1	6
HXK	Holder, Needle; Orthopedic	888.4540	1	5
HXN	Applier, Cerclage	888.4540	1	2
HXO	Pusher, Socket	888.4540	1	3
HXP	Instrument, Bending Or Contouring	888.4540	1	5
HXQ	Crimper, Pin	888.4540	1	0
HXS	Twister, Wire	888.4540	1	2
HXW	Bender	888.4540	1	3
HXX	Screwdriver	888.4540	1	4
HXY	Brace, Drill	888.4540	1	7
HXZ	Cutter, Wire	888.4540	1	1
KIL	Positioner, Socket	888.4540	1	1
LXH	Orthopedic Manual Surgical Instrument	888.4540	1	58
LYQ	Accessories, Fixation, Spinal Intervertebral Body	888.4540	1	3
LYS	Bone Mill	888.4540	1	4
OCJ	Spinal Channeling Instrument, Vertebroplasty	888.4540	1	1
QWL	Intraoperative Surgical Angle Measurement Tool	888.4560	2	3
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	888.4580	2	23
LZV	System, Cement Removal Extraction	888.4580	2	7
HTH	Protractor	888.4600	1	3
HWT	Template	888.4800	1	10
HST	Apparatus, Traction, Non-Powered	888.5850	1	38
HSP	Splint, Traction	888.5890	1	1
HSQ	Belt, Pelvic, Traction	888.5890	1	1
HSR	Unit, Traction, Hip, Non-Powered, Non-Penetrating	888.5890	1	1
HSS	Halter, Head, Traction	888.5890	1	3
KQZ	Component, Traction, Non-Invasive	888.5890	1	11
QZO	Wearable Vibration Device For Orthopedic Use	888.5895	2	1
LGF	Component, Cast	888.5940	1	31
LGH	Instrument, Cast Removal, Ac-Powered	888.5960	1	9
LGG	Instrument, Cast Application/Removal, Manual	888.5980	1	3
LOF	Stimulator, Bone Growth, Non-Invasive	890.5870	2	11
LPQ	Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep	890.5870	2	0

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