# K200656: Delta Multihole TT Pro Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jul 8, 2020 after 118 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 13 generations back to K810258 (1981). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191622: Delta Multihole TT Pro Acetabular System, Lima Corporate S.P.A. (2019) Summary page 4.
- K182099: Delta TT Pro, Lima Corporate S.P.A. (2018) Summary page 4.
- K140669: G7 Osseoti Acetublar Shells, Biomet, Inc. (2014) Summary page 4.

## Indications for use
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; • Rheumatoid arthritis; • Post-traumatic arthritis, • Correction of functional deformity; • Fractures, dislocation of the hip and unsuccessful cup arthroplasty; • Revisions in cases of good remaining bone stock; • Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only). The Delta Acetabular System is intended for cementless use.

Source page: https://510kreport.com/device/K200656
Methodology: https://510kreport.com/methodology