# K993768: Citation TMZF HA Stem

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 21, 2000 after 74 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941141 (1994). 6 ancestors in all.
224 later devices descend from it; 3 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972228: Meridian Titanium Femoral Stems, Howmedica, Inc. (1997) Summary page 1.
- K955871: Howmedica Asymmetric Stem Femoral Component, Howmedica Corp. (1996) Summary page 1.
- K941366: Osteonics Omnifit AD-HA Hip Stem Series, Osteonics Corp. (1995) Summary page 1.

## Most influential descendants
- K001448: Trident Acetabular Shells: PS-HA (2000), 150 descendants of its own
- K013106: 2 Piece Modular Hip Stem (2002), 101 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own

## Recalls of this device
- Feb 3, 2014 · Class II · Z-1317-2014: Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 deg
- Jan 6, 2009 · Not classified · Z-1374-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1381-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1379-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1380-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1378-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1376-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1375-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1382-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1377-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Nov 12, 2002 · Not classified · Z-0349-03: Hip Stem Fractures in the neck area.
- Nov 12, 2002 · Not classified · Z-0350-03: Hip Stem Fractures in the neck area.

## Indications for use
The Citation TMZF HA Stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is also indicated for use in revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K993768
Methodology: https://510kreport.com/methodology