Biomet has received FDA 510(k) clearance for the Signature Personalized Patient Care System for total knee replacements, according to a company news release.
The Signature system provides patient-matched guides for using total knee replacement surgery paired with Biomet implants. Combined with the MRI or CT images, advanced surgical planning software can tailor the surgery to each specific patient.
The company sought FDA clearance to resolve an issue raised by the FDA in a warning letter sent on July 27, 2010. The clearance means the company is prepared for future submissions on the application of Signature technology to the treatment of orthopedic conditions, said Jeff Binder, president and CEO of Biomet, in the release.
Read the Biomet news release on the Signature system (pdf).
Read other coverage on Biomet:
- Biomet Reports Flat Net Sales at $698.3M for 2Q
- Biomet Completes Enrollment for FDA Trial of PRP Device for Tennis Elbow Treatment
- Biomet Sports Medicine Mobile Learning Center to Provide Product Demonstration and Education
The Signature system provides patient-matched guides for using total knee replacement surgery paired with Biomet implants. Combined with the MRI or CT images, advanced surgical planning software can tailor the surgery to each specific patient.
The company sought FDA clearance to resolve an issue raised by the FDA in a warning letter sent on July 27, 2010. The clearance means the company is prepared for future submissions on the application of Signature technology to the treatment of orthopedic conditions, said Jeff Binder, president and CEO of Biomet, in the release.
Read the Biomet news release on the Signature system (pdf).
Read other coverage on Biomet:
- Biomet Reports Flat Net Sales at $698.3M for 2Q
- Biomet Completes Enrollment for FDA Trial of PRP Device for Tennis Elbow Treatment
- Biomet Sports Medicine Mobile Learning Center to Provide Product Demonstration and Education