B-ONE ORTHO, CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3015259876	3015259876	B-ONE ORTHO, CORP.	1	Y	2026-01-01	3 Wing Drive Suite #259 Cedar Knolls NJ US 07927
3016093326	3016093326	B-ONE ORTHO, CORP.	1	Y	2020-04-25	636 Shelby Street Floor 4 Bristol TN US 37620

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
226371	1402405631	K253357	b-ONE® Bipolar Head	KWY	2026-04-13
226371	1219564302	K240528	b-ONE® Total Hip System	LZO	2024-11-15
226371	1969580502	K222431	b-ONER MOBIO Total Knee System	JWH	2022-10-06
226371	1667441525	K213673	b-ONE MOBIO Total Knee System	JWH	2022-01-21
226371	2056499470	K210483	MOBIO Total Knee System	JWH	2021-04-21
226371	1007727253	K202768	KOSMO Femoral Stem	LZO	2021-04-01
226371	1959815932	K202429	Mobio Total Knee System	JWH	2020-10-23
226371	1827677341	K183025	MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component	JWH	2019-01-28
226371	1964195446	K182705	Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups	LZO	2019-02-14
226371	1766541431	K180446	b-ONE Total Knee System	JWH	2018-10-12
226371	1066316163	K173380	b-ONE® Total Hip System	LZO	2018-08-30
226371	1008671229
226371	1088236822
226371	1147306631
226371	1277981507
226371	1550998243
226371	1561811394
226371	1604755259
226371	1664622438
226371	1672580004
226371	1715266937
226371	1717053521
226371	1835889517
226371	1901544582
226371	2003499480
226371	2030434793
226371	2038953734
226371	2071999118

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JWH	6	2022-10-06
LZO	4	2024-11-15
KWY	1	2026-04-13

PMN#

b-ONE® Total Hip System
2024-11-15
B-One Ortho, Corp.
B-ONER MOBIO Total Knee System
2022-10-06
B-ONE ORTHO, Corp.
B-ONE MOBIO Total Knee System
2022-01-21
B-ONE ORTHO, Corp.
MOBIO Total Knee System
2021-04-21
B-ONE ORTHO, Corp.
Mobio Total Knee System
2020-10-23
B-One Ortho, Corp.

GUDID#

MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 9mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 10mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 11mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 13mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 16mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 19mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 22mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert, Size BC/1-2, 25mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 9mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 10mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 11mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 13mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 16mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 19mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 22mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS+ Tibial Insert, Size BC/1-2+, 25mm thickness, Vitamin E UHMWPE
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 9mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 10mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 11mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 13mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 16mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 19mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 22mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS Tibial Insert Trial, Size BC/1-2, 25mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 9mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 10mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 11mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 13mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 16mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 19mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 22mm
B-ONE ORTHO, CORP.
2026-05-29
MOBIO™ Total Knee System - PS PLUS Tibial Insert Trial, Size BC/1-2+, 25mm
B-ONE ORTHO, CORP.
2026-05-29
Juveno™ Femoral Hip System - Femoral Head/Liner Impactor Tray
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 50mm Outer Diameter; Size E Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 50mm Outer Diameter; Size F Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 52mm Outer Diameter; Size F Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 52mm Outer Diameter; Size G Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 54mm Outer Diameter; Size G Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 54mm Outer Diameter; Size H Liner
B-ONE ORTHO, CORP.
2026-05-29
Primo™ Acetabular System - Cementless Acetabular Shell; Full Hole; Porous Plasma Spray; 56mm Outer Diameter; Size H Liner
B-ONE ORTHO, CORP.
2026-05-29

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