# K141395: Delta TT Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jun 30, 2014 after 33 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: 9 generations back to K931641 (1994). 78 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws, Lima Corporate S.P.A. (2012)
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 2.

## Most influential descendants
- K182099: Delta TT Pro (2018), 3 descendants of its own
- K191622: Delta Multihole TT Pro Acetabular System (2019), 2 descendants of its own
- K150855: H-MAX S Femoral Hip System (2015), 2 descendants of its own
- K172456: Bone Screws 6.5mm (2018), 1 descendant of its own
- K160011: H-Max S stem (2016), 1 descendant of its own

## Recalls of this device
- Sep 8, 2017 · Class II · Z-0068-2018: An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and

## Indications for use
The Delta TT 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. The Delta TT cup is intended for cementless use.

Source page: https://510kreport.com/device/K141395
Methodology: https://510kreport.com/methodology