# K170473: C2 femoral stem

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Nov 8, 2017 after 265 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 236 ancestors in all.
No later device cites it as a predicate yet.
1 of 237 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112091: H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 5.
- K150855: H-MAX S Femoral Hip System, Lima Corporate S.P.A. (2015) Summary page 5.
- K160011: H-Max S stem, Lima Corporate S.P.A. (2016) Summary page 5.
- K962101: Zweymueller SL Femoral Hip Stem, Intermedics Orthopedics (1996) Summary page 5.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 5.
- K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 5.
- K072852: SL-Plus Standard and Lateral Hip Stems, Smith & Nephew, Inc. (2008) Summary page 5.
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 5.
- K143096: SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA, Smith & Nephew, Inc. (2015) Summary page 5.

## Indications for use
Monolithic cementless stems are indicated for use in partial or total hip arthroplasty and they are intended for press-fit (uncemented) use. When used in total hip arthroplasty, monolithic cementless stems are intended for use with modular heads and compatible acetabular cups. When used in partial hip arthroplasty, they are intended for use with bipolar heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: * non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and dysplasia; * theumatoid arthritis; * revisions in cases of good remaining femoral bone stock; * treatment of femoral head and neck fractures.

Source page: https://510kreport.com/device/K170473
Methodology: https://510kreport.com/methodology