Summit Basic Press-Fit Hip Stem
510(k) K030122
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030122 | Date5 Feb 2003 | 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- Withdrawn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
- Full name
- Depuy Summit Basic Press-Fit Hip Stem
- 510(k) Number
- FDA product code
- LWJ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Summit Basic Press-Fit Hip Stem is a cementless, press-fit hip prosthesis stem designed for primary total hip arthroplasty. It is manufactured from titanium alloy and features a rough, grit-blasted surface finish to enhance osseointegration. Available in seven sizes, it is intended for secure fixation within the femoral canal without cement. The device falls under the classification of a hip prosthesis and is engineered to provide stable, long-term support for hip joint replacement procedures.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It requires surgical implantation by a trained professional, typically following templating and reaming to achieve proper sizing. The Summit Basic Press-Fit Hip Stem is FDA-cleared under a Special 510(k) pathway (K030122) and adheres to orthopedic device standards. Storage should follow manufacturer guidelines to maintain sterility and integrity prior to use.
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the DePuy Summit Basic Press-Fit Hip Stem used for?
The DePuy Summit Basic Press-Fit Hip Stem is designed specifically for primary total hip arthroplasty (replacement surgery). Its cementless, press-fit design allows for secure fixation within the femoral canal without the use of bone cement. The rough, grit-blasted titanium alloy surface promotes osseointegration—meaning it encourages bone to grow directly onto the stem—for stable, long-term support in hip joint replacement procedures.
How is the Summit Basic Press-Fit Hip Stem supplied and prepared for use?
The device is supplied sterile and intended for single-use in surgical settings. Before implantation, the surgeon follows templating and reaming steps to ensure proper sizing of the femoral canal. The stem is then press-fit into place, relying on its rough surface texture to achieve secure fixation without additional cement. This process requires surgical expertise and adherence to manufacturer guidelines.
Is the Summit Basic Press-Fit Hip Stem reusable, or is it meant for one-time use?
The Summit Basic Press-Fit Hip Stem is explicitly intended for single-use only. Its sterile packaging and design specifications (including the grit-blasted surface and titanium alloy construction) are optimized for one surgical procedure. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or clinical outcomes.
What sizes are available for the Summit Basic Press-Fit Hip Stem?
The device comes in seven distinct sizes to accommodate varying femoral canal dimensions. The sizing is tailored to ensure a secure press-fit within the bone, reducing the risk of loosening or instability post-surgery. Surgeons select the appropriate size based on preoperative templating and intraoperative assessment to optimize fit and function.
How should the Summit Basic Press-Fit Hip Stem be stored before use?
To maintain sterility and integrity, the Summit Basic Press-Fit Hip Stem must be stored according to the manufacturer’s guidelines. This typically includes keeping the sterile packaging unopened, sealed, and protected from contamination or physical damage. Storage should occur in a clean, controlled environment (e.g., operating room or sterile supply area) away from direct sunlight, moisture, or extreme temperatures until immediately before use.