BIOLOX delta Option and Extra-long Heads
510(k) K173776
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173776 | Date6 Jul 2018 | 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- Withdrawn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
- LZO
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BIOLOX delta Option and Extra-long Heads are ceramic hip implants designed for total hip arthroplasty. These components are engineered to provide durable articulation in hip replacements, utilizing a high-performance ceramic material to reduce wear and friction compared to traditional metal-on-polyethylene bearings.
These heads are supplied as single-use, sterile implants intended for use in orthopedic surgical settings. They are available in option and extra-long lengths to accommodate varying anatomical requirements. The device holds an FDA 510(k) clearance under product code LZO, with a traditional review process and substantial equivalence determination. Storage and handling must comply with sterile medical device protocols.
From the manufacturer
CeramTec BIOLOX® delta Ceramic Hip Heads The pink color of BIOLOX® delta ceramic gives surgeons the certainty that they're using implants of the highest quality and reliability for their patients - from CeramTec, BIOLOX® delta is the only ceramic with 15 years of successful clinical experience - with more than 8 million components sold.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip replacements are these ceramic heads designed for, and why is ceramic preferred in this context?
The BIOLOX delta Option and Extra-long Heads are specifically designed for total hip arthroplasty, a surgical procedure to replace a damaged hip joint. Ceramic is preferred here because it reduces wear and friction compared to traditional metal-on-polyethylene bearings, which can lead to longer-lasting implants and fewer complications over time.
Are these heads reusable, or are they intended for single-use only? How should they be handled to maintain sterility?
These heads are intended for single-use only and are supplied in a sterile package. To maintain sterility, they must be handled according to standard sterile medical device protocols—never opened or exposed to non-sterile environments before surgery.
What length options are available, and why might a surgeon choose the extra-long version over the standard option?
The BIOLOX delta heads come in Option and Extra-long lengths to accommodate different anatomical needs. The extra-long version may be selected when a patient’s anatomy requires greater femoral head coverage or offset adjustments, ensuring a better fit and improved biomechanics during hip replacement.
How is the regulatory pathway for this device structured, and what does the product code LZO indicate?
This device follows the FDA 510(k) clearance pathway, determined to be substantially equivalent to a legally marketed predicate under product code LZO, which categorizes orthopedic hip prostheses. The traditional review process and substantial equivalence designation mean it was evaluated against existing hip implants to ensure safety and effectiveness.