# K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Corin, Ltd.
- Decided: Jul 28, 2021 after 405 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K810258 (1981). 398 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 400 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 21.
- K110087: Corin Trinity Acetbular System with Hxlpe Liners, Corin USA (2011) Summary page 21.
- K111481: Corin Trinity Acetabular System Ecima Liners, Corin USA (2012) Summary page 21.
- K122305: Corin Trinity-I Acetabular Shell, Corin USA (2012) Summary page 21.
- K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells, Corin USA (2013) Summary page 21.
- K130128: Trinity Acetabular System, Corin Medical (2013) Summary page 21.
- K130343: Corin Trinity Acetabular System with Extra-Long Heads, Corin USA (2013) Summary page 21.
- K131647: Trinity Acetabular System, Corin USA (2013) Summary page 21.
- K172551: Trinity PLUS Acetabular Shell, Corin U.S.A. Limited (2018) Summary page 21.
- K082525: Corin Metafix Femoral Stem, Corin USA (2010) Summary page 21.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 21.
- K121439: Metafix Femoral Hip Stem Size 1, Corin USA (2012) Summary page 21.
- K153381: Corin Metafix Hip Stem, Corin U.S.A. Limited (2016) Summary page 21.
- K173880: Corin TriFit CF Hip Stem, Corin U.S.A. Limited (2018) Summary page 21.
- K121563: Corin Trifit TS Hip, Corin USA (2012) Summary page 21.
- K153772: Corin TriFit TS Hip, Corin U.S.A. Limited (2016) Summary page 21.
- K992234: The Taper-Fit Total Hip System, Corin USA (1999) Summary page 21.
- K003666: Taper-Fit Total Hip System, Corin USA (2001) Summary page 21.
- K142761: Corin TaperFit Hip Stem, Corin USA (2015) Summary page 21.
- K153725: Corin TaperFit Hip Stem, Corin U.S.A. Limited (2016) Summary page 21.
- K152903: REVIVAL (TM) Modular Revision Hip Stem, Corin USA (2016) Summary page 21.
- K191374: Revival Modular Hip Stem, Corin U.S.A. Limited (2019) Summary page 21.
- K083312: Minihip Stem, Corin USA (2010) Summary page 21.
- K111046: Corin Minihip Femoral Stem, Corin USA (2011) Summary page 21.
- K131986: Corin Minihip Stem, Corin USA (2013) Summary page 21.
- K103120: Corin Biolox Delta Femoral Heads, Corin USA (2011) Summary page 21.
- K170359: Trinity™ Dual Mobility System, Corin U.S.A. Limited (2017) Summary page 21.
- K191831: MobiliT Cup, Corin U.S.A. Limited (2020) Summary page 21.
- K183114: Corin BiPolar-i, Corin U.S.A. Limited (2019) Summary page 21.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 21.
- K041950: Apex K2 Hip System, Apex Surgical, LLC (2004) Summary page 21.
- K060072: Monoblock Press-Fit Hip Stem, Omni Life Science, Inc. (2006) Summary page 21.
- K110947: Apex K1 Hip Stem, Omni Life Science, Inc. (2011) Summary page 21.
- K101451: Apex Module Hip System Biolox Delta Femoral Head, Omni Life Science, Inc. (2010) Summary page 21.
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60), Omni Life Science, Inc. (2009) Summary page 21.
- K100151: Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM), Omnlife Science (2010) Summary page 21.

## Most influential descendants
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own

## Indications for use
The BiPolar-i is intended for use in the following indications: Non-innammatOI)' degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only. The Trinity Acetabular System is indicated for use in non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, developmental dysplasia of the hip (DOH) or congenital dysplasia of the hip (CDH). The Trinity Acetabular System is intended for cementless, single use only. The indications for the Corin Meta FixTM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis · Rheumatoid arthritis · Correction of functional deformity · Treatment of non-union and femoral neck fractures · Developmental dysplasia of the hip (DOH) and congenital dysplasia of the hip (CDH) The Corin MetaFixTM Hip Stem is indicated for cementless use only. The indications for the MiniHip Stem as a total hip arthroplasty include:· Non-innammatory degenerative joint disease including osteoarthritis and avascular necrosis· Rheumatoid arthritis· Correction of functional defom1ity· Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)The MiniHip Stem is indicated forcementless use only. The indications for the TrinityT" Acetabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional defom1ity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acetabular System is intended for cementless, single use only. The TriniryT" Dual Mobility System is intended for use in the following indications: I. Non-innammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional defonnity 4. Revision of previously failed total hip arthroplasry 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). TI,e TrinityTM Dual Mobility System is indicated for cementless use only. The indications for the Corin TrinityTM PLUS Acetabular Shell as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Revision of previously failed t otal hip arthroplasty, Developmental dysplasia of the hip (DOH). The TrinityTM PLUS Acetabular Shell is indicated for cement less use only. The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - In cases of fi-acture ofthe neck of the femur - In cases of congenital luxation The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only. The cemented MobiliT Cup is indicated for cemented use only. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed. The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acetabular System or bipolar component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; • Correction of functional defom1ity; • Congenital dislocation; Revision procedures where other treatments or devices have failed; • Femoral neck and trochanteric fractures of the proximal femur. The indications for use of the- OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-innammatory degenerative joint disease, including osteoarthritis a.nd avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; • Congenital dislocation; - Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation. The indications for use of the- OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-innammatory degenerative joint disease, including osteoarthritis a.nd avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; • Congenital dislocation; - Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation. The Revival"" Modular Revision Hip Stem is indicated in rev,s,on surgery of femoral components, following failure of primary cemented or 1111-cemented prosthesis. T he REVIVAL™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-innammatory degenerative joint disease including primary and secondary osteoarthritis, Rheumatoid arthritis, Correction of functional defonnity, Treatment of non-union and femoral neck fractures, Treatment oftraumatic dislocations ofthe hip, Failures ofosteotomy, Treatment ofarthrodesis. The Revival TM Modular Revision Hip Stem is indicated for cementless, single use only. TaperFitTM Hip Stem is indicated for the relief of pain and restoration of hip function following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The TaperFit Hip Stern is indicated for hemi-arthroplasty when used in combination with Corin hemi-arthroplasty femoral heads. The TaperFitT" Hip Stern is indicated for cemented, single use only. The indications for use of the K1 Hip Stem in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K1 Hip Stem is indicated for cementless use only and single use implantation. The indications for the Tri Fit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The TriFit CF Hip Stem is indicated for cementless use only. The indications for the Corin Tri Fit TS™ Hip as a total hip arthroplasry, and when used in combination with a Corin hemi arthroplast:y head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoa,thritis and avascular necrosis, Rheumatoid arthritis, Correction of functional defom1ity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The TriFit TS Hip is intended for cementless use only.

Source page: https://510kreport.com/device/K201657
Methodology: https://510kreport.com/methodology