# K190057: DJO Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jun 7, 2019 after 147 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 122 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072888: Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared), Encore Medical L.P. (2008) Summary page 4.
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner, Encore Medical L.P. (2013) Summary page 4.
- K172651: FMP Extended Liners, Encore Medical L.P. (2017) Summary page 4.
- K931665: 6.5 MM Cancellous Bone Screw, Encore Orthopedics, Inc. (1994) Summary page 4.
- K121874: G7 Acetabular System, Biomet Manufacturing Corp (2012) Summary page 4.
- K040412: Trident T Acetabular Shells, Stryker Orthopaedics (2004) Summary page 4.

## Most influential descendants
- K251833: EMPOWR Acetabular® Liner Extension (2025), 0 descendants of its own
- K191708: Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (2020), 0 descendants of its own

## Recalls of this device
- Jan 5, 2026 · Class II · Z-1234-2026: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cau
- Aug 22, 2023 · Class II · Z-0103-2024: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery 
- Aug 12, 2022 · Class II · Z-0125-2023: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
- Sep 9, 2020 · Class II · Z-0135-2021: Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
- Oct 22, 2019 · Class II · Z-1929-2020: The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: • noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; • rheumatoid arthritis; • correction of functional deformity; • femoral fracture. This device may also be indicated in the salvage of previously failed surgical attempts. This device is indicated for cementless use.

Source page: https://510kreport.com/device/K190057
Methodology: https://510kreport.com/methodology