Who else makes this device?

Name: Axiom
Brand: Axiom

Axiom · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer → Orthopedic

10manufacturers in China registered for this device type

33catalogue numbers in this listing

1510(k) clearance

3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRY
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
Suzhou Microport Orthorecon Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	31

Record

Regulatory record for Axiom
Listed by	Microport Orthopedics Inc., United States
FDA product code	HRY
Device type	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3530
Establishment	Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2015-10-20
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Sizes	Height 10 to 30 mm

Catalogue Numbers

Catalogue numbers for Axiom
Catalogue number	Size	Status
1290551400	Height 14 mm	In distribution
1422701000	Height 10 mm	In distribution
1290601200	Height 12 mm	In distribution
1422751000	Height 10 mm	In distribution
1290551000	Height 10 mm	In distribution
1310601200	Height 12 mm	In distribution
1310551000	Height 10 mm	In distribution
1422801200	Height 12 mm	In distribution
1421601400	Height 14 mm	In distribution
1290601400	Height 14 mm	In distribution
1422751200	Height 12 mm	In distribution
1290601000	Height 10 mm	In distribution
1290601700	Height 17 mm	In distribution
1421602000	Height 20 mm	In distribution
1310601700	Height 17 mm	In distribution
1422651000	Height 10 mm	In distribution
1422651200	Height 12 mm	In distribution
1422601200	Height 12 mm	In distribution
1310601400	Height 14 mm	In distribution
1422601000	Height 10 mm	In distribution
1422651400	Height 14 mm	In distribution
1310551700	Height 17 mm	In distribution
1422701200	Height 12 mm	In distribution
1290551200	Height 12 mm	In distribution
1422751400	Height 14 mm	In distribution
1422702000	Height 20 mm	In distribution
1422751700	Height 17 mm	In distribution
1421603000	Height 30 mm	In distribution
1310551200	Height 12 mm	In distribution
1310602000	Height 20 mm	In distribution
1310601000	Height 10 mm	In distribution
1421601000	Height 10 mm	In distribution
1290551700	Height 17 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Legion	Smith & Nephew, Inc.	1,682
Genesis II	Smith & Nephew, Inc.	615
Journey II	Smith & Nephew, Inc.	581
Evolution	Microport Orthopedics Inc.	311
Profix	Smith & Nephew, Inc.	293
Journey	Smith & Nephew, Inc.	215
LinkSymphoKnee	Waldemar Link GmbH & Co. KG	201
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Smith & Nephew, Inc.	160
JII	Smith & Nephew, Inc.	141
Physica KR	Limacorporate	128
Physica LMC	Limacorporate	120
Implant Partners	Microport Orthopedics Inc.	119

Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152631	2016-03-23

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
2024-05-03	Class II	Under Investigation by firm	One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Fe	40 units
2022-10-28	Class II	Nonconforming Material/Component	One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.	24 units	2026-09-10
2022-10-28	Class II	Nonconforming Material/Component	One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.	22 units	2026-09-10

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P840049	1988-09-30	P.C.A.(TM) TOTAL KNEE SYSTEM	Howmedica Corp.

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.

Axiom