# K052171: Zimmer Ambulatory Pump Pain Management System with Patient Control Module

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 13, 2005 after 65 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896422 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050433: Zimmer Ambulatory Pump Pain Management System, Zimmer Orthopaedic Surgical Products (2005) Summary page 1.

## Most influential descendants
- K053226: Zimmer Ambulatory Pump Pain Management Systems  with Fenestrated Catheter and Flow Splitter (2006), 0 descendants of its own

## Indications for use
The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Source page: https://510kreport.com/device/K052171
Methodology: https://510kreport.com/methodology