MPO Hip Instruments
510(k) K213816
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213816 | Date5 Jan 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDI
- FDA applicant
- Microport Orthopedics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The MPO Hip Instruments are orthopedic surgical instruments designed for use in total hip arthroplasty procedures. These instruments assist in the preparation of the femoral canal, acetabular component positioning, and implant fixation, supporting precise bone resection and component alignment during hip replacement surgery.
These instruments are supplied as reusable surgical tools and are intended for use in sterile operating room environments. They are classified under FDA product code JDI and were granted a Special 510(k) clearance by the Orthopedic (OR) Advisory Committee in January 2022. Compliance with regulatory standards ensures their suitability for clinical use in hip arthroplasty procedures.
From the manufacturer
With over 50 years of clinical history, MicroPort Orthopedics has extensive experience in all aspects of Total Hip Arthroplasty (THA). We offer a full range of acetabular systems and femoral stems in various styles and philosophies to complement our range of surgical approaches.
PRECAUTIONS & DISCLAIMERS Every patient is different, and individual results will vary. There are risks and recovery times associated with surgery. *The SkyWalker® Surgical Robot is an FDA cleared system of MicroPort NaviBot International LLC and a CE marked system of MicroPort Orthopedics (Suzhou) Co., Ltd. MicroPort Orthopedics Inc. is a distributor for MicroPort NaviBot.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
Are the MPO Hip Instruments designed for single-use or can they be reused in multiple procedures?
The MPO Hip Instruments are explicitly supplied as reusable surgical tools, meaning they are intended for repeated use in multiple sterile operating room environments. Since they are designed for total hip arthroplasty procedures, proper cleaning, sterilization, and maintenance protocols must be followed between uses to ensure safety and efficacy.
What types of hip replacement surgeries are these instruments intended to assist with?
These instruments are designed for total hip arthroplasty procedures, specifically to assist with femoral canal preparation, acetabular component positioning, and implant fixation. They help surgeons achieve precise bone resection and proper alignment of hip replacement components during surgery.
How are the MPO Hip Instruments regulated in the U.S., and what does that mean for clinicians?
The MPO Hip Instruments received FDA 510(k) clearance through a Special 510(k) pathway, reviewed by the Orthopedic (OR) Advisory Committee in January 2022. This means the FDA determined they are substantially equivalent to a legally marketed predicate device, confirming their compliance with regulatory standards for use in total hip arthroplasty. Clinicians can rely on this clearance as evidence of their safety and performance for approved surgical applications.
What should clinicians consider when storing these reusable instruments?
Since the MPO Hip Instruments are reusable, proper storage is critical to maintain their integrity and sterility. They should be stored in a clean, dry environment—preferably in a dedicated instrument tray or case—protected from moisture, dust, and physical damage. If not in use, they should be kept in a way that prevents cross-contamination between procedures, such as in a sterilized state or with appropriate packaging until ready for reprocessing.
What does the FDA product code *JDI* indicate about these instruments?
The FDA product code JDI classifies these instruments under the Orthopedic Powered Surgical Instruments category. This classification helps regulators, clinicians, and purchasing departments identify that the MPO Hip Instruments fall within orthopedic surgical tools—specifically those used in powered or precision-guided procedures like total hip arthroplasty—ensuring they meet the appropriate safety and performance standards for their intended use.