SMITH & NEPHEW PLATFORM HIP STEM

K052275 · Smith & Nephew, Inc. · LZO · Dec 7, 2005 · Orthopedic

Device Facts

Record IDK052275
Device NameSMITH & NEPHEW PLATFORM HIP STEM
ApplicantSmith & Nephew, Inc.
Product CodeLZO · Orthopedic
Decision DateDec 7, 2005
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 888.3353
Device ClassClass 2
AttributesTherapeutic

Intended Use

Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Platform Hip Stem components are for single use only.

Device Story

Prosthetic hip joint system; features 12/14 taper; used with existing Smith & Nephew femoral heads and acetabular components. Designed for uncemented implantation in hip arthroplasty. Operates as mechanical support for hip joint; restores function in patients with degenerative or traumatic hip conditions. Used by orthopedic surgeons in clinical/surgical settings. Provides structural stability to proximal femur; enables joint articulation; facilitates patient rehabilitation. Single-use device.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical test report data indicating the device is capable of withstanding expected in vivo loading without failure.

Technological Characteristics

Material: Ti-6Al-4V (ASTM F 136). Design: 12/14 taper; femoral stem geometry. Intended for uncemented use. Semi-constrained prosthesis.

Indications for Use

Indicated for individuals undergoing primary or revision total hip arthroplasty due to trauma, inflammatory joint disease (e.g., rheumatoid arthritis), noninflammatory degenerative joint disease (e.g., osteoarthritis), avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant, remote osteomyelitis, nonunion, or proximal femur fractures unmanageable by other techniques.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K052275 Smith & Nephew, Inc. Summary of Safety and Effectiveness Smith & Nephew Platform Hip Stem DEC 7 2005 Date of Summary: August 19, 2005 Contact Person and Address Gino Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6707 Name of Device: Smith & Nephew Platform Hip Stem Common Name: Prosthetic hip joint ## Device Description Device Description The Smith & Nephew I fattorin The Stem features a 12/14 taper and is used with circulouralpezondar neek geomed y. Trade and acetabular components. The Platform existing Smith & Nephew femoral heads and acetabular components. 126 existing Sintti & Nophow Tom Ti-6Al-4V conforming to ASTM F 136. ## Device Classification Device Classification 21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis – Class II Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II ## Mechanical and Clinical Data Mechanical and Chinear Data A review of the test report data indicated that the Smith & Nephew of with at and A review of the test report data marcated and is capable of withstanding expected in vivo loading without failure. ### Indications for Use Indications for USE Total hip components are indicated for uncemented use in individuals undergoing Total hip components are increated for anteased in antestant or devices have failed in primary and revision stagery where other trauma, inflammatory joint disease such as rehabilitating hips damaged as a result of trauma, inflammace (AJID) or any rehabilitating inps damaged as a result of themes and the joint disease (NIDID) or any rheumatoid arthritis, or nonin'Ilammatory degenerative joint disease (NIDIO) or any ati of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic of its composite diagnoses such as ontocal in fracture of the pelvis; diastrophic arthritis; slipped capital epith sistem inp; inced inp; included drainage-free period; nonunity hond variant; old, remote osteonlychtle with & was and the proximal femur with head. femoral neck fracture and trochanterie in other techniques; femoral osteotomy, of involvement that are unmanageable using other techniques; of deformity involvement that are unmanagedore asing of the hip; and correction of deformity. Girdlestone resection, fracture assisted as a for single use only. # Substantial Equivalence Information Substantial Equivalence of the Smith & Nephew Platform Hip Stem is based on its similarities in indications for use, design features, operational principles, and its similarities in mulcations for use, design rote devices – Plus Orthopedics SLmaterial composition to the following predicate devices – Plus Orther Alleon material composition to the following predicate devices - Services - Services Alloclassic {1}------------------------------------------------ Zweymuller SL/SLL Femoral Hip Stems (K030373), Smith & Nephew Modular Hip Stepher States (Kenthe Suritis & Nephaw Sustem (K963509), K991485 Zweymuller SL/SLL Femoral Hip Stems (R050573), Shiftin Corregion (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip System (K963509, K991485, Stem (K042127) and K002996). : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 2005 DEC ? Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 Re: K052275 K03273 Trade/Device Name: Smith & Nephew Platform Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LWJ Dated: November 17, 2005 Received: November 21, 2005 Dear Mr. Rouss: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematics is substantially equivalent (for the indications referenced above and have determined the device is substantials; in interests referenced above and have determined the arresed predicate devices marketed in interstate for use stated in the enclosure) to regary mancede producal Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Enderal Food. Drug commerce prof to May 20, 1970, the chacinent and second of the Federal Food. Drug, devices that have been reciassified in accordance with approval application (PMA). and Cosmetic Act (Act) that do not require approval assessed approval application of the Ac and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the devreet, belyer to the s general controls provisions of the Act include requirements for answer michrending and general controls provisions of the Helens - and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into ennier regulations affecting your device can may be subject to such additional controls. Existing major regulations all any may be subject to such additional controller Entitle of Parts 800 to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 and 11 be found in the Code of Peachal Negarding your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a subscription with other requirements of the Act that FDA has made a determination that your device complies. You must that FDA has made a determination administered by other Federal agencies. You must or any Federal statures and regulations administered or registration and listing (21 comply with all the Act's requirements, including, but not limited to: set comply with an the Act S requirements, mercesses wouldeduring practice requirements as set CFR Part 807), rabening (21 CFR Part 600); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Gino J. Rouss This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin manteang your and equivalence of your device to a legally premits that notheation. The PDA mining of casting of your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your donee of (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comphaller and (21 transmit (21CFR Part 807.97). You may obtain Missuranuing o'y reference to premains to premails the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Z Ser Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k (0) 2275 Device Name: Smith & Nephew Platform Hip Stem Indications for Use: Total hip components are indicated for uncemented use in individuals undergoing primary and rolar hip compensions ar ther treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Platform Hip Stem components are for single use only. AND/OR Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Co 121 CFR 807.9 Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not WRITE BELOW THIS Line – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign=1 Division of General, Restorative, and Neurological Devices Page 1 of _ 510(k) Number_10 S
Innolitics
510(k) Summary
Decision Summary
Classification Order
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