# K140701: Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug

- Pathway: 510(k) (Traditional)
- Applicant: Novosource, Inc.
- Decided: Jun 27, 2014 after 99 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: 9 generations back to K810258 (1981). 73 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132158: Novohip Total Hip System, Novosource, Inc. (2014) Summary page 1.
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 1.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 1.

## Most influential descendants
- K151424: The Progressive Orthopaedic Total Hip System (2016), 1 descendant of its own
- K192450: Precision Casting Solutions Total Hip System (2019), 0 descendants of its own

## Indications for use
NovoHip Vitamnin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovaSource hip implant components arc indicated for use in cenientless reconstruction of the articulating surface of femoral and/or aectabular portions of the hip that are severely disabled and/or very painful as a result of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis or traumatic arthritis - Correction of functional dcformiy - Non-union femoral neck fracture - Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques. The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Source page: https://510kreport.com/device/K140701
Methodology: https://510kreport.com/methodology