# K112898: Delta TT Cups, Delta TT Liners, Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Dec 21, 2012 after 445 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: 8 generations back to K931641 (1994). 77 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 2.
- K070369: Regenerx Ringloc + Modular Acetabular Shells, Biomet, Inc. (2007) Summary page 2.
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 2.
- K960094: Reflection Dual Dimension Shell, Smith & Nephew Richards, Inc. (1996) Summary page 2.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000)
- K102975: Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole, Exactech, Inc. (2010) Summary page 2.
- K973119: Foundation Porous Acetabular System, Encore Orthopedics, Inc. (1998) Summary page 2.
- K974093: Foundation Porous Coated Hemispherical Shell, Encore Orthopedics, Inc. (1998) Summary page 2.
- K974095: Foundation Porous Coated Flared Rim Shell, Encore Orthopedics, Inc. (1998) Summary page 2.
- K072154: Foundation (FMP) Porous Coated Spiked Acetabular System, Encore Medical L.P. (2007) Summary page 2.
- K850766: Zimmer Threaded Acetabular Cup, Zimmer, Inc. (1985) Summary page 2.
- K021891: Zimmer Trabecular Metal Modular Acetabular System, Zimmer, Inc. (2002) Summary page 2.
- K953490: Trilogy Acetabular Shell & Liners 36MM, Zimmer, Inc. (1995) Summary page 2.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 2.
- K851213: Zweymuller Cup, Allo Pro Corp. (1985) Summary page 2.

## Most influential descendants
- K141395: Delta TT Acetabular System (2014), 10 descendants of its own
- 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

## 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/K112898
Methodology: https://510kreport.com/methodology