# K172456: Bone Screws 6.5mm

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jan 4, 2018 after 143 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 229 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 231 devices in its family (counting itself) has 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) Summary page 6.
- K141395: Delta TT Acetabular System, Lima Corporate S.P.A. (2014) Summary page 6.
- K110598: SMR Reverse Shoulder System, Lima Corporate S.P.A. (2011) Summary page 6.
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws, Lima Corporate S.P.A. (2012) Summary page 6.
- K133349: SMR TT Metal Back Glenoid, Lima Corporate S.P.A. (2014) Summary page 6.
- K161120: SMR TT Metal Back Glenoid, Bone Graft instruments, Lima Corporate S.P.A. (2017) Summary page 6.
- K163397: SMR Hybrid Glenoid System, Lima Corporate S.P.A. (2017) Summary page 6.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 9.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 9.
- K113121: Comprehensive Reverse Shoulder, Biomet Manufacturing, Inc. (2011) Summary page 9.
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 9.
- K161863: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA), Stryker GmbH (2016) Summary page 9.

## Most influential descendants
- K183042: SMR Lateralized Connectors with screws (2019), 0 descendants of its own

## Recalls of this device
- Oct 1, 2021 · Class II · Z-0159-2022: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
- Oct 1, 2021 · Class II · Z-0160-2022: There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

## Indications for use
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: • non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • inflammatory degenerative joint disease such as rheumatoid arthritis; • treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; • revision of a failed primary implant; • cuff tear arthropathy (CTA Heads only); • glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table. In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct. On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented. 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.

Source page: https://510kreport.com/device/K172456
Methodology: https://510kreport.com/methodology