RESTORATION MEDICAL POLYMERS

FDA Device Registration & Listing · Columbia City, IN, US · Registration 3015916578

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015916578
FEI Number
3015916578
Entity Name
RESTORATION MEDICAL POLYMERS
City/State/Country
Columbia City, IN, US
Establishment Address
4474 East Park 30 Drive, Columbia City, IN 46725, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Restoration Medical Polymers (Owner Number: 10078694)
Owner / Operator Contact Address
4474 East Park 30 Drive, Columbia City, IN 46725, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LCG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2021-11-02
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2021-11-02
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2020-11-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-11-02
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-11-02
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2020-11-02
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-11-02
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-11-20
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-09
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-09
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-12-09
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-12-09
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-12-09

Official Correspondent

Jordan Freedman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Restoration Medical Polymers
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K780299 Richard'S Medical Equip., Inc. TOTAL KNEE SYSTEM 1978-04-27
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25
K153310 Total Joint Orthopedics, Inc. Klassic Knee System 2015-12-17
K102380 Wrightmedicaltechnologyinc EVOLUTION MP TOTAL KNEE SYSTEM 2011-01-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2008 N/A 2
EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0020-2022 Exactech, Inc. 2
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015916578. Last updated year: 2026. Please use registration number 3015916578 when referencing this establishment in official correspondence.
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