FDA 510(k) Recap: Joint Replacement Updates and Line Extensions

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Orthopedics’ major players continually receive FDA 510(k) clearances for product updates and line extensions to their joint replacement portfolios. Cleared submissions year to date addressed new component designs, packaging and sterilization options, additional materials and manufacturing facilities, etc.

In total, 32 joint replacement products were cleared in 2020 to date. Here, we recap 12 that fit the filter for updates and extensions.

Knee Devices

Arthrex | iBalance UKA Tibial Tray Implant, K200433 (pictured above)

  • Submitted February 2020, granted March 2020
  • Primary predicates: ACCIN UNI-Knee System, K060670; Arthrex iBalance BiCompartmental Arthroplasty System, K160461
  • This Special 510(k) premarket notification is submitted to gain clearance for a new tibial tray model as a line extension to the Arthrex iBalance UKA System cleared under K060670.
  • The subject device is a new tibial tray made of the same CoCr materials as the predicate. The tray is offered in sizes 1-6 and available for the left medial/right-lateral and right-medial/left-lateral compartments.
  • The subject device is designed for use with the cleared tibial bearing and femoral implants of the Arthrex iBalance UKA System.

Conformis | iUni Unicondylar Knee, iDuo Bicompartmental Knee, iTotal CR Knee, iTotal PS Knee Replacement, K193105

  • Submitted November 2019, granted March 2020
  • Primary predicate: Conformis iTotal Cruciate Retaining (CR) Knee Replacement, K180906
  • Secondary predicates: iUni Unicondylar Knee, K132640, K133256; iDuo Bicompartmental Knee, K093513, K133256; iTotal Posterior Stabilized (PS) Knee, K161668
  • This 510(k) adds the option to sterilize device components using the Steris VHP LTS-V sterilizer

DePuy Ireland | ATTUNE All-Polyethylene Tibia, K193057

  • Submitted November 2019, granted January 2020
  • Primary predicates: Darwin Knee System, Johnson & Johnson Professional, K943462; Darwin Knee System (Cruciate-Substituting) Porous Coated and NonPorous Coated, Johnson & Johnson Professional, K950010; P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professional, K961685; P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professional, K971189; DePuy ATTUNE Knee System, DePuy Orthopaedics, K101433
  • This 510(k) submission is to add the ATTUNE All Polyethylene Tibia to the currently cleared ATTUNE Knee.
  • The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components and existing ATTUNE patella components (K103756).

Smith+Nephew | LEGION Inserts with JRNY Lock, K200407

  • Submitted February 2020, granted March 2020
  • Primary predicate: Smith & Nephew, Crosslinked Polyethylene Articular Inserts, K071071
  • The subject devices are tibia insert components, a line extension of LEGION CR High Flex and Deep Dish inserts cleared under premarket notification K071071.
  • Subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the JOURNEY II CR and JOURNEY II BCS inserts, cleared under premarket notifications K121443 and K111711, respectively.
  • Subject LEGION Inserts have a size range of 1-2, 3-4, 5-6 and 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18 and 21mm, and come in cruciate-retaining high flexion (CR HF) and Deep Dish varieties.

Hip Devices

DePuy Orthopaedics | Summit DuoFix HA Coating, K193398

  • Submitted December 2019, granted February 2020
  • Primary predicate: DePuy Porocoat Hip Prosthesis, K170339, K011489, K001911
  • This submission supports the manufacturing of Summit DuoFix HA Coating components at an additional manufacturing facility for all process steps currently performed at DePuy Ireland. This includes the HA coating process step within the DePuy Ireland manufacturing site.
  • There are also two alternative sterilization sites added for Business Continuity Purposes.
  • The submission includes a modification to the packaging; converting from an outer thermoformed blister package and film pouch inner to a polyurethane sleeve protector, which is vacuumed sealed in a nylon pouch which is placed inside an outer PETG blister sealed with a Tyvek lid.

Kyocera Medical Technologies (KMTI) | Tesera Trabecular Technologies (T3) Acetabular Shell System Porous Acetabular Cup, K200328

  • Submitted February 2020, granted March 2020
  • Primary predicate: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell, K132312
  • Renovis Surgical Technologies is now wholly owned by Kyocera International as Kyocera Medical Technologies.
  • The subject of this Special 510(k) Premarket Notification are additional KMTI offerings which include the use of components of the Kyocera Medical, Japan Initia Total Hip (K160895 ) (now Kyocera Corp) that may be used with the KMTI T3 acetabular shell (K132312), porous acetabular shell (K141676 ) and KMTI universal acetabular liners.

Medacta | AMIStem-C, K193433

  • Submitted December 2019, granted January 2020
  • Primary predicate: Medacta Total Hip Prosthesis– AMIStem C & QUADRA C Short Neck, K103189
  • The AMIStem-C femoral stem size 00 is a line extension of the stems to the currently marketed AMIStem-C product line.
  • The subject device and predicate AMIStem-C femoral stems are identical in materials of construction, surface finish, biocompatibility, device usage, sterility, shelf-life and packaging.
  • The subject AMIStem-C femoral stem provides a smaller stem length and neck offset than the currently available AMIStem-C stems; these differences do not introduce a new worst case from a clinical point of view or with respect to the biomechanical performance of the implants.

Zimmer Biomet | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads, K192683

  • Submitted September 2019, granted February 2020
  • Primary predicate: Biomet UK Biolox delta Ceramic Heads, K131684; Biomet UK Biolox delta Option Ceramic Heads, K141653
  • This submission is to notify FDA of cumulative changes to the Biolox delta Ceramic Heads and Biolox delta Option Ceramic Heads relating to a manufacturing site transfer for the subject devices, a change of sterilization sub-contractor, labeling changes (including changes to IFU and labels) and packaging changes following the manufacturing site transfer and device compatibility (inclusion of additional compatible products)

Extremity Devices

Arthrex | Univers Revers Modular Glenoid System (Augmented baseplates), K193372

  • Submitted December 2019, granted January 2020
  • Primary predicate: Arthrex Univers Revers Modular Glenoid System, K173900
  • This special 510(k) premarket notification is submitted to obtain clearance for additional modular baseplates and posts as a line extension to the Univers Revers Modular Glenoid System cleared under K173900.

DePuy Ireland | DELTA XTEND Reverse Shoulder, K192855

  • Submitted October 2019, granted February 2020
  • Primary predicates: DePuy Synthes GLOBAL UNITE Platform Shoulder, K170748 and DELTA XTEND Reverse Shoulder K071379, K120174
  • Current submission is a line extension to DELTA XTEND Reverse Shoulder System to add additional epiphysis device components.
  • Further, this submission supports the addition of MRI compatibility language to the labeling for the currently marketed, FDA cleared, DELTA XTEND Reverse Shoulder System and GLOBAL UNITE Platform Shoulder

Exactech | Equinoxe Reverse Shoulder Glenospheres, K193098

  • Submitted November 2019, granted February 2020
  • Preliminary predicate: Exactech Equinoxe Reverse Shoulder, K063569; Equinoxe Reverse Shoulder 36mm Glenosphere and Humeral Liners, K093275; Equinoxe Reverse Shoulder Line Extensions, K110708; Equinoxe Reverse Shoulder 46x21mm Glenosphere, K150458
  • The Exactech Equinoxe Reverse Shoulder Glenospheres and Extended Locking Cap are used in reverse total shoulder arthroplasty.
  • Modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Glenospheres and Locking Cap; these geometry modifications are the entire basis for the proposed devices.

FX Shoulder USA | Glenoid Baseplate with Screw, K192799

  • Submitted September 2019, granted February 2020
  • Primary predicate: FX Shoulder Humelock II Reversible Shoulder, K150488; Humelock Reversed Shoulder, K162455; Humeris Shoulder, K163669
  • The subject device is a design modification of the primary predicate that does not raise new questions of safety and effectiveness and is substantially equivalent to the primary predicate.
  • This new component, Glenoid Baseplate with Screw, is substantially equivalent to the primary predicate as it is identical to the primary predicate on indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility and compatible components.

 

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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