# K132158: Novohip Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Novosource, Inc.
- Decided: Feb 21, 2014 after 224 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 38 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935484: Provident Hip System, Stelkast Company (1994) Summary page 1.
- K033944: Stelkast 32MM Modular Ceramic Femoral Head, Stelkast Company (2004) Summary page 1.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 1.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 1.

## Most influential descendants
- K143314: Progressive Orthopaedic Total Hip System (2015), 2 descendants of its own
- K140701: Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug (2014), 2 descendants of its own
- K213842: ONVOY Acetabular System (2022), 1 descendant of its own
- K151424: The Progressive Orthopaedic Total Hip System (2016), 1 descendant of its own
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own

## Recalls of this device
- Sep 19, 2024 · Class II · Z-0483-2025: Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

## Indications for use
NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/ar very painful as a result of: * Non-inflammatory degenerative joint disease including osteoarthritls and avascular necrosis * Rheumatoid arthritis or traumatic arthritis * Correction of functional deformity * 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/K132158
Methodology: https://510kreport.com/methodology