510(k) Report

PMA · Approved

Recalled · Class II · 2021

Birmingham Hip Resurfacing (BHR) System

P040033PMAApproved May 9, 2006659-day reviewClass IIIRecalls 29

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Approved on May 9, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 659-day review. It has been recalled 29 times.

Decided
May 9, 2006
Review
659 days
Class
Class III
Product code
NXT
Recalls
29

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P040033 has 36 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2006: 12007: 32008: 42009: 62010: 22011: 42012: 12014: 42015: 22016: 22017: 12018: 22022: 12023: 12024: 12025: 1
2006high 6 (2009) · low 0 (2013)2025
View FIG. 1 as a table
YearSupplements approved
20061
20073
20084
20096
20102
20114
20121
20144
20152
20162
20171
20182
20221
20231
20241
20251
FIG. 1 — Supplements to P040033, 2006–2025Source: FDA PMA database

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 14, 2021Class IIZ-2242-2021Component change controlThe nail head may become detached during surgery.
May 11, 2018Class IIZ-2268-2018Process controlThe affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were…
May 11, 2018Class IIZ-2267-2018Process controlThe affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were…
Jun 3, 2015Class IIZ-2745-2015Device DesignThe firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Jun 3, 2015Class IIZ-2747-2015Device DesignThe firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Jun 3, 2015Class IIZ-2746-2015Device DesignThe firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Jul 12, 2007Not classifiedZ-0016-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0020-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0027-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0029-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0031-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0017-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0018-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0019-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0021-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0022-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0024-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0028-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0033-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0023-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0025-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0026-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0030-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Jul 12, 2007Not classifiedZ-0032-2008Packaging process controlThe carton label may not reflect the correct size of the acetabular cup.
Mar 13, 2007Not classifiedZ-0866-2007OtherThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Mar 13, 2007Not classifiedZ-0863-2007OtherThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Mar 13, 2007Not classifiedZ-0865-2007OtherThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Mar 13, 2007Not classifiedZ-0862-2007OtherThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Mar 13, 2007Not classifiedZ-0864-2007OtherThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.

The 5 latest of 29 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All NXT devices

NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NXT

1in 2025

2007: 62008: 62009: 92010: 42011: 72012: 12013: 12014: 52015: 22016: 32017: 12018: 22020: 12022: 12023: 12024: 12025: 1
2007high 9 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NXT

Too few NXT 510(k)s in any year since 2007 to give a median.

Recalls per year · NXT

No recall names NXT since 2007.

Adverse event reports per year · NXT

91in 2025

2007: 142008: 92009: 1372010: 2592011: 4222012: 5022013: 6992014: 7002015: 3632016: 3582017: 4602018: 5792019: 4682020: 5342021: 5282022: 4252023: 1432024: 1592025: 91
2007high 700 (2014) · low 9 (2008)2025

MAUDE reports naming product code NXT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076—014
20086—09
20099—0137
20104—0259
20117—0422
20121—0502
20131—0699
20145—0700
20152—0363
20163—0358
20171—0460
20182—0579
20190—0468
20201—0534
20210—0528
20221—0425
20231—0143
20241—0159
20251—091
20260—0—

More from Smith & Nephew, Inc.

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Recent decisions in NXT

The NXT category page

  • P040033/S039Birmingham Hip™ Resurfacing (BHR) SystemSmith & Nephew, Inc. · 2025
  • P040033/S038Birmingham Hip Resurfacing (BHR) SystemSmith & Nephew, Inc. · 2024
  • P040033/S037Birmingham Hip Resurfacing (BHR) SystemSmith & Nephew, Inc. · 2023
  • P040033/S036Birmingham Hip Resurfacing (BHR) SystemSmith & Nephew, Inc. · 2022
  • P050016/S012Cormet Hip Resurfacing SystemCorin USA · 2020

https://510kreport.com/device/P040033 · printed Nov 6, 2026

Cite this page

510(k) Report. “P040033: Birmingham Hip Resurfacing (BHR) System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040033

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026