# K071723: Zimmer Porolock Mis Stem

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Mar 7, 2008 after 256 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K850055 (1985). 44 ancestors in all.
73 later devices descend from it; 8 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032726: Zimmer M/L Taper Hip Prosthesis, 7711 Series, Zimmer, Inc. (2003) Summary page 2.
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads, Zimmer GmbH (2006) Summary page 2.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.

## Most influential descendants
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K130899: Biolox Delta Ceramic Femoral Heads (2013), 19 descendants of its own
- K120030: Taperloc Complete Size 4MM and XR 123 (2012), 14 descendants of its own
- K121034: Ioi Total Hip (2012), 11 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0320-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Sep 4, 2012 · Class II · Z-0220-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 

## Indications for use
This femoral stem is for total or hemi-hip arthoplasty and is indicated for the following conditions: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (J10), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed 1ip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the 4tuality of their lives, This stem is for uncemented use only.

Source page: https://510kreport.com/device/K071723
Methodology: https://510kreport.com/methodology