What is FDA product code NPJ?

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

Orthopedic › ProstheticProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Scorpio

Name: Scorpio
Brand: Scorpio

Catalogue number 73-20-3110, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NPJ
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

Record

Regulatory record for Scorpio
Listed by	Howmedica Osteonics Corp, United States
FDA product code	NPJ
Device type	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3560
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer
510(k)	K051977
Record published	2015-09-24
Record revised	2021-02-05 (version 4)

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

Catalogue Numbers

Catalogue numbers for Scorpio
Catalogue number	Size	Status
73-20-3110	Size: 11	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Restoris	Mako Surgical Corp.	101
Sigma	Depuy (Ireland)	64
Instrument	Howmedica Osteonics Corp	62
Triathlon	Howmedica Osteonics Corp	33
Journey	Smith & Nephew, Inc.	24
iDuo® iPoly™ Insert Kit	ConforMIS, Inc.	15
Restoris Esyntial	Mako Surgical Corp.	13
Mako	Mako Surgical Corp.	7
Specialty Triathlon TS Trial Assessment Guide Size 8 Right	Howmedica Osteonics Corp	6
iDuo® Patella Trial	ConforMIS, Inc.	4
Unix	Howmedica Osteonics Corp	3
iDuo® Patella Sizer	ConforMIS, Inc.	3

Showing 12 of 21. All products under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K052917	2005-12-27

Recalls Naming This Product

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

Recalls naming the identifiers of Scorpio
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Howmedica Osteonics Corp	510(k) number	2026-07-30	Not classified	Process change control	Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to	12,156 US
Howmedica Osteonics Corp	510(k) number	2011-08-17	Not classified	Other	Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.	26,648 units	2014-03-26

Recalls

The FDA has not published a severity grade for these. 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
2004-10-27	Not classified	Other	The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.	386 UNITS	2005-05-31

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.