Who else makes this device?

Name: AcuMatch
Brand: AcuMatch

AcuMatch · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented → Orthopedic

13manufacturers in China registered for this device type

9catalogue numbers in this listing

12510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDI
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
B-ONE Medical (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	23
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
b-ONE Medical (Beijing) Co., Ltd.	Beijing	Beijing	Contract manufacturer	7
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54

Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Record

Regulatory record for AcuMatch
Listed by	Exactech, Inc., United States
FDA product code	JDI
Device type	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class	Class 2
Regulation	21 CFR 888.3350
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K010120
Record published	2022-08-25
Record revised	2025-08-28 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number
Sizes	Outer diameter 9 to 31 mm; length 135 to 165 mm
Distribution end date	2024-06-13

Catalogue Numbers

Catalogue numbers for AcuMatch
Catalogue number	Size	Status
113-05-01	SZ 1	In distribution
107-11-00		In distribution
151-05-29	Outer Diameter 29 mm	Withdrawn
151-05-31	Outer Diameter 31 mm	Withdrawn
151-06-09	Length 135 mm	Withdrawn
151-06-13	Pilot Outer Diameter	Withdrawn
151-05-25	Outer Diameter 25 mm	Withdrawn
151-05-23	Outer Diameter 23 mm	Withdrawn
153-01-00	12/14	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Zimmer, Inc.	836
R3	Smith & Nephew, Inc.	497
UniSyn Hip System	Shalby Advanced Technologies, Inc.	247
UniSyn® Hip System	Consensus Orthopedics, Inc.	247
Reflection	Smith & Nephew, Inc.	170
Instrument	Howmedica Osteonics Corp	167
Echelon	Smith & Nephew, Inc.	159
B-P Total HIP System	Endotec, Inc.	151
ZCA®	Zimmer, Inc.	149
Omnifit	Howmedica Osteonics Corp	149
Ringloc HIP System	Biomet Orthopedics	139
Profemur	Microport Orthopedics Inc.	113

Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K051335	2005-06-21
K023646	2002-11-13
K020291	2002-02-27
K012493	2001-08-29
K011218	2001-05-16
K001335	2000-05-18
K964262	1996-12-27
K963313	1996-11-14
K961304	1996-10-01
K925201	1993-06-15
K901297	1990-05-02
K862234	1986-10-15

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of AcuMatch
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Exactech, Inc.	510(k) number	2022-08-11	Class II	Process control	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.	132 devices
Exactech, Inc.	510(k) number	2007-11-01	Not classified	Process control	Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 – 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm	10	2012-05-06
Exactech, Inc.	510(k) number	2006-07-21	Not classified	Other	The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.	6	2012-05-06

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-08-11	Class II	Process control	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.	7946 devices
2022-08-11	Class II	Process control	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.	4956 devices
2016-11-07	Class II	Under Investigation by firm	Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.	79 units	2019-08-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

AcuMatch