Anterior Approach Hip Surgery Instruments
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K102565
Overview
These instruments are designed for use in total hip arthroplasty via the anterior approach. They include stainless steel surgical tools such as broaches, inserters/impactors, chisels, and rasps, which assist in preparing the proximal femur and positioning hip implants.
The instruments are intended for use in clinical orthopedic settings and are supplied as reusable surgical tools. They are classified as Class III devices under FDA regulations and were granted Special 510(k) clearance (K102565) in 2010. No information regarding sterility or MRI safety is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK102565 | Date22 Dec 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
Are these instruments designed for single-use or can they be reused in multiple procedures?
These instruments are explicitly described as reusable surgical tools intended for use in total hip arthroplasty via the anterior approach. Since they are classified as reusable, they are meant to be cleaned, sterilized, and reused across multiple procedures in clinical orthopedic settings.
What types of surgical tools are included in this set, and how do they assist in the procedure?
The set includes stainless steel surgical tools such as broaches, inserters/impactors, chisels, and rasps. These tools are designed to prepare the proximal femur and help position hip implants during total hip arthroplasty via the anterior approach, ensuring proper fit and alignment of the prosthesis.
How are these instruments supplied, and what should I consider regarding their maintenance?
The instruments are supplied as a reusable kit for clinical orthopedic use. Since they are not sterile by default (no sterility information is provided), they must be properly cleaned, sterilized, and maintained between uses to ensure safety and functionality. Follow established protocols for stainless steel surgical instruments to prevent contamination and preserve their integrity.
What is the regulatory pathway for these instruments, and how were they cleared by the FDA?
These instruments were granted Special 510(k) clearance (K102565) by the FDA in 2010 under the Orthopedic advisory committee. They are classified as Class III devices and were determined to be substantially equivalent to a predicate device, meaning their safety and effectiveness were compared to an already-approved product.
Are these instruments compatible with any specific hip implant systems, or are they general-purpose tools?
While the instruments are designed for use in total hip arthroplasty via the anterior approach, the provided data does not specify compatibility with particular implant brands or systems. They are general-purpose tools intended to assist in preparing the femur and positioning semi-constrained metal uncemented acetabular components, as referenced in the associated FDA records.