# K181340: Cemented TSI Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Feb 11, 2019 after 266 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Signature Orthopaedics TSI Stem: named in the summary without a submission number
- (no number) Signature Orthopaedics Evolve Stem: named in the summary without a submission number
- (no number) Smith & Nephew Synergy Cemented Stem: named in the summary without a submission number
- (no number) Signature Orthopaedics Avail Stem: named in the summary without a submission number
- (no number) Signature Orthopaedics [device name illegible in OCR]: named in the summary without a submission number

## Most influential descendants
- K192024: Cemented TSI Hip Stem (2020), 0 descendants of its own

## Indications for use
Signature Orthopaedics Cemented TSI Hip Stem is indicated for replacement of the hip where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: • Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis • Inflammatory joint disease including rheumatoid arthritis • Correction of functional deformity including congenital hip dysplasia • Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture • Failed previous hip surgery including failed internal fixation or joint fusion, reconstructive, hemiarthroplasty, surface replacement, or total replacement

Source page: https://510kreport.com/device/K181340
Methodology: https://510kreport.com/methodology