# K122783: Plasmafit Acetabular Cup and Vitelene Insert

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Oct 30, 2013 after 414 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 187 ancestors in all.
No later device cites it as a predicate yet.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042344: Excia Total Hip System, Aesculap, Inc. (2005) Summary page 3.
- K061699: EXCIA, Aesculap, Inc. (2006) Summary page 3.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 3.
- K112115: Mectacer Biolox (R) Delta Femoral Heads, Medacta International (2011). Our reading of the summary gave K111215, FDA’s number for Ascom Mobile Monitoring Gateway (MMG) (Ascom (Sweden) AB). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mectacer 40mm Biolox Delta Heads”.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 3.

## Indications for use
The Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for use with existing Aesculap femoral heads and femoral stems to replace the hip joint. The devices are intended for: * Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur * Patients with congenital hip dlysplasia, protrusion acetabuli, or slipped capital femoral ephiphysis * Patients suffering from disability due to previous fusion * Patients with acute femoral neck fractures Plasmafit Pro Acetabular Cup System and Vitelene Insert are intended for cementless applications.

Source page: https://510kreport.com/device/K122783
Methodology: https://510kreport.com/methodology