# K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 6, 2009 after 156 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 9 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K170444: PROCOTYL® PRIME Acetabular Cup System (2017), 16 descendants of its own
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner (2017), 10 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K122382: Dynasty Biofoam Shell (2012), 5 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own

## Recalls of this device
- Jan 3, 2012 · Not classified · Z-1022-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1017-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1020-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1021-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1026-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1027-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1018-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1019-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1016-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1023-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1024-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1025-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1028-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1029-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1030-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jan 3, 2012 · Not classified · Z-1031-2012: The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision
- Jun 7, 2010 · Not classified · Z-2212-2010: The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.

## Indications for use
The DYNASTY® 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: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision. The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device.

Source page: https://510kreport.com/device/K082924
Methodology: https://510kreport.com/methodology