Who else makes this device?

Name: FLS Plate, TMT,
Brand: FLS Plate, TMT,

FLS Plate, TMT, · Plate, Fixation, Bone → Orthopedic

22manufacturers in China registered for this device type

2catalogue numbers in this listing

6510(k) clearances naming this product code

16recalls on this code

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRS
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
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
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Suzhou Kangli Orthopaedics Instrument Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	11
Kingj Medical Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	7
Hangzhou Sino-MIM Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	6
Suzhou AND Science & Technology Development Corp.	Zhangjiagang	Jiangsu	Contract manufacturer	5
Beijing AK Medical Co., Ltd.	Changping District	Beijing	Contract manufacturer	3

Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone

Record

Regulatory record for FLS Plate, TMT,
Listed by	I.T.S. Gmbh, Austria
FDA product code	HRS
Device type	Plate, Fixation, Bone
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Complaint-file establishment, Manufacturer
510(k)	K131722
Record published	2016-09-12
Record revised	2026-06-19 (version 8)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for FLS Plate, TMT,
Catalogue number	Size	Status
21492-2		In distribution
21491-2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pectus System	Biomet Microfixation	4,662
Arthrex®	Arthrex, Inc.	3,031
Evos	Smith & Nephew, Inc.	2,235
Peri-Loc	Smith & Nephew, Inc.	2,196
OsteoMed	Osteomed	1,961
VariAx	Stryker GmbH	1,934
Aptus	Medartis Inc.	1,688
TC-100	Smith & Nephew, Inc.	1,639
Plate, Fixation, Bone	Synthes Gmbh	1,613
Anthem	Globus Medical, Inc.	1,551
Acumed	Acumed LLC	1,360
Signex	Osteonic Co., Ltd.	1,310

Showing 12 of 3,530. All products under Plate, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260958	2026-06-16
K260054	2026-04-24
K210935	2022-08-31
K142418	2014-09-26
K131722	2013-08-07
K130008	2013-06-25

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of FLS Plate, TMT,
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
I.T.S. Gmbh	510(k) number	2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	15,517 units

Recalls

15 of these are Class II. Class II means a temporary or reversible health consequence. 14 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. 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
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	70 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	292 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	4 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	11 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	46,637 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	120 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	322 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	101 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	1,307 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	176 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	510 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	220 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	12,059 units
2026-01-23	Class II	No Marketing Application	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).	869 units
2019-05-09	Class II	Labeling mix-ups	The titanium implant has the wrong article number laser marked on it.	65 devices

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.

FLS Plate, TMT,