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HTR-PEKK

Model PK626605-A · OXFORD PERFORMANCE MATERIALS, INC. · DI 00810128537131

KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction · Class II · 21 CFR 878.3500

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-02: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 1.6/device2019-04: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 6/device2026-02: 0 reports for this device; peer average 2/device020304120102030407081006080910050610020910041011030102
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201.25
2019-0301.6
2019-0402
2019-1201
2020-0101.5
2020-0201.33
2020-0303
2020-0401
2020-0701
2020-0801
2020-1001
2021-0603
2021-0801
2021-0902
2021-1001
2022-0501
2022-0601
2022-1001
2023-0201.67
2023-0902.5
2023-1001
2024-0401
2024-1001
2024-1101.5
2025-0303
2026-0106
2026-0202
This device (reports/month)Average device in KKY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K161052 — cites (transitively): K133809 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — OXFORD PERFORMANCE MATERIALS, INC.

  • Warning Letter 2017-05-01 Oxford Performance Materials, Inc.
  • Warning Letter 2017-05-01 Oxford Performance Materials, Inc.
  • VAI 2024-08-02 Oxford Performance Materials, Inc. · 1 citations
  • VAI 2024-08-02 Oxford Performance Materials, Inc. · 1 citations
  • VAI 2017-11-21 Oxford Performance Materials, Inc. · 3 citations
  • VAI 2017-11-21 Oxford Performance Materials, Inc. · 3 citations
  • OAI 2017-04-07 Oxford Performance Materials, Inc. · 5 citations
  • OAI 2017-04-07 Oxford Performance Materials, Inc. · 5 citations
  • VAI 2013-12-20 Oxford Performance Materials, Inc. · 1 citations
  • VAI 2013-12-20 Oxford Performance Materials, Inc. · 1 citations