# K163585: Responsive Orthopedics Total Hip Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Responsive Orthopedics, LLC
- Decided: Jun 2, 2017 after 164 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: 5 generations back to K935452 (1994). 94 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K920430: Modular Acetabular Cup System, Smith & Nephew Richards, Inc. (1992) Summary page 4.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 4.
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 4.
- K110245: United Utf Stem, United Orthopedic Corporation (2011) Summary page 4.
- K111546: U2 Hip System, United Orthopedic Corp. (2011) Summary page 5.
- K103479: Novel Tapered Hip Stem, Stryker Corp. (2011) Summary page 5.
- K022520: U2 Acetabular Cup, United Orthopedic Corp. (2003) Summary page 5.
- K062775: European Style Taper,Press-Fit Hip Stem, Ortho Development Corp. (2007) Summary page 5.

## Most influential descendants
- K183129: Medtronic Total Hip Arthroplasty System (2019), 0 descendants of its own

## Indications for use
The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases: • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and • Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.

Source page: https://510kreport.com/device/K163585
Methodology: https://510kreport.com/methodology