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Sign in to claim this brandNovosource, Inc.
US
Last updated May 23, 2026
What Novosource, Inc. makes
Novosource, Inc. manufactures reusable and prefabricated orthopedic implants for joint replacement procedures, including knee and hip prostheses. Their portfolio includes trial components for knee and acetabulum implants, as well as total knee systems with posterior-stabilized and cruciate-retaining designs. The company also produces press-fit hip femur prostheses and reusable joint prosthesis implantation kits.
The devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Novosource, Inc. manufacture?
Novosource, Inc. specializes in reusable and prefabricated orthopedic implants primarily for joint replacement surgeries. Their product portfolio includes knee and hip prostheses, such as total knee systems (both posterior-stabilized and cruciate-retaining designs), press-fit hip femur prostheses, and reusable trial components for knee and acetabulum implants. These devices are designed to assist surgeons during procedures like joint prosthesis implantation.
Where is Novosource, Inc. based?
Novosource, Inc. is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it influences the jurisdiction under which its devices may be authorized and monitored.
Which regulatory registries list Novosource, Inc.’s devices?
Novosource, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.
How are Novosource, Inc.’s devices classified under FDA regulations?
Novosource, Inc.’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification determines the regulatory pathway and oversight required for each device.
What distinguishes Novosource’s reusable orthopedic implants from other similar products?
Novosource’s reusable orthopedic implants are designed for repeated use in surgical procedures, which can reduce costs and waste compared to single-use alternatives. Their portfolio includes trial components for fitting and testing implants before permanent placement, as well as specialized designs like press-fit hip prostheses and total knee systems with distinct stabilization features. These features cater to surgeons’ needs for precision and flexibility during joint replacement surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (901)
Page 18 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NovoHip Total Hip System | 1400-2802 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1204-5232 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-1026 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-2052 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1500-1016 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-4056 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1100-1625 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1450-0002 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1400-2250 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1204-5832 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1100-1250 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-1055 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-1016 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1300-3604 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1500-1061 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1500-1041 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1500-1057 | FDA UDI | Class I | Active |
| NovoKnee Total Knee System | 3211-0006-A | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-2012 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-2021 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1280-5032 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-4021 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1335-2800 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1200-6632 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-4054 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1345-3204 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1611-100-001 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-4051 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1100-2250 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1220-0066 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1713-154-101 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1400-3202 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3101-1106 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1215-5436 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1325-3203 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1200-6228 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1335-2803 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-3055 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1310-3600 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1500-0032 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3115-1105 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3311-4035 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 1210-0064 | FDA UDI | Class II | Active |
| NovoKnee Total Knee System | 3301-1045 | FDA UDI | Class II | Active |
| NovoHip Total Hip System | 1445-3605 | FDA UDI | Class II | Active |
| Novosource Total Hip System | 2200-5236 | FDA UDI | Class II | Active |
| Tk1 Total Knee System | K123339 | FDA 510(k) | Class II | Active |
| Novoknee Total Knee System | K131398 | FDA 510(k) | Class II | Active |
| NovoKnee (SteriKnee) | K261032 | FDA 510(k) | Class II | Active |
| Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug | K140701 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Novosource, Inc. has one FDA recall record initiated on September 19, 2024. The recall is listed with both open and classified statuses. The reason provided is that a product was mislabeled, specifically packaged in a box marked as containing a 32-long item but actually containing a 28-long head, which may affect product performance if implanted.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 19, 2024 | Z-0483-2025 | — | open, classified | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted |